Outpatient Surgery, Abdominal Surgery, Breast Surgery
Conditions
Keywords
Opioids, Surgery, Postoperative Period, Postoperative Pain, Analgesia, Pain Management
Brief summary
North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.
Detailed description
This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.
Interventions
Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
Sponsors
Society of American Gastrointestinal and Endoscopic Surgeons
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Patient-reported outcomes and treatment adherence data will be collected via self-administered electronic questionnaires distributed using REDCap (http://project-redcap.org/) and completed by patients via smartphone, tablet or personal computer. Electronic outcome data will be transmitted directly to the REDCap database and verified by a blinded assessor. Adherence data will be verified by unblinded study staff. Patients who are not computer savvy, have limited access or prefer non-electronic assessment will complete the questionnaires via telephone interviews with a blinded assessor; in this case, data will be recorded in paper forms and subsequently transferred to the REDCap database. Outcome data that are not patient-reported (e.g. postoperative complications, unplanned healthcare utilization, chronic opioid use), will be obtained from medical records by a blinded assessor.
Intervention model description
This study will be a parallel, two-group, assessor-blind, pilot randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (\>18 yo) undergoing outpatient surgery * Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies) * Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)
Exclusion criteria
All patients * Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay * Contraindications to any of the drugs used in the trial * Difficult to be reached after surgery * Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Screened Participants Who Were Eligible to Participate in the Study | 4 months | At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized. |
| Percentage of Surgeons Agreeing and Adhering to Patient Randomization | 4 months | At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds). |
| Percentage of Eligible Patients Agreeing to Participate | 4 months | At least 50% of eligible patients agree to participate in the study and are randomized. |
| Percentage of Randomized Patients Complying With Allocated Treatment | 4 months | At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed). |
| Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment | 4 months | At least 80% of the randomized patients complete outcome assessment at 30 days after surgery. |
| Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments | 4 months | Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%. |
| Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments | 4 months | Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Drug Events | 30 days after surgery | Obtained from spontaneous patient reporting (Trigger question Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system. |
| Postoperative Pain | 30 days. | Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes. |
| Comprehensive Complication Index at 30-day | 30 days | Measured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications. |
| Rate of Prolonged Opioid Use | 3 months | Filling of opioid prescriptions up to 3 months after surgery. |
| Time to Stopping Pain Medication | 30 days. | The time to the first report of stopping the use of pain medication. |
| Postoperative Health Status | Weeks 1, 2, 3 and 4 after surgery. | Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured. |
| Opioid Side-effects | Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery | Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. The reported rates indicate the number of reported events per period of evaluation. |
| Rate of Opioid Misuse | 4 weeks | Measured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to \>1 question indicates the patient exhibits prescription opioid misuse. |
| Postoperative Complications Classification | 30 days. | Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse). Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic |
| Rate of Unplanned Healthcare Utilization | 30 days. | Emergency department visits, hospital readmissions. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid Analgesia Opioid analgesics: Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. | 39 |
| Opioid-free Analgesia Non-opioid analgesics: Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. | 37 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded owing to intraoperative complication requiring hospital stay | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Opioid Analgesia | Opioid-free Analgesia |
|---|---|---|---|
| Abdominal Surgery | 40 Participants | 20 Participants | 20 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 14.5 | 54.3 years STANDARD_DEVIATION 15.1 | 56.8 years STANDARD_DEVIATION 14 |
| American Society of Anesthesiology score I | 15 Participants | 6 Participants | 9 Participants |
| American Society of Anesthesiology score II | 53 Participants | 25 Participants | 28 Participants |
| American Society of Anesthesiology score III | 8 Participants | 2 Participants | 6 Participants |
| Amount of opioids received in the PACU | 21 MME STANDARD_DEVIATION 18 | 18 MME STANDARD_DEVIATION 14 | 25 MME STANDARD_DEVIATION 21 |
| BMI | 27.6 kg/m2 STANDARD_DEVIATION 7 | 26.4 kg/m2 STANDARD_DEVIATION 4.7 | 28.8 kg/m2 STANDARD_DEVIATION 8.7 |
| BMI >= 30.0 | 18 Participants | 7 Participants | 11 Participants |
| Breast surgery | 36 Participants | 19 Participants | 17 Participants |
| Current smoker | 13 Participants | 8 Participants | 5 Participants |
| Duration of surgery | 91 min STANDARD_DEVIATION 45 | 97 min STANDARD_DEVIATION 39 | 84 min STANDARD_DEVIATION 51 |
| Employed, including self-employed | 44 Participants | 24 Participants | 20 Participants |
| Homemaker | 2 Participants | 2 Participants | 0 Participants |
| Laparoscopic appendectomy | 1 Participants | 0 Participants | 1 Participants |
| Laparoscopic cholecystectomy | 9 Participants | 3 Participants | 6 Participants |
| Laparoscopic inguinal hernia repair | 9 Participants | 8 Participants | 1 Participants |
| Open incisional hernia repair | 1 Participants | 0 Participants | 1 Participants |
| Open inguinal hernia repair | 17 Participants | 8 Participants | 9 Participants |
| Open umbilical hernia repair | 3 Participants | 1 Participants | 2 Participants |
| Pain catastrophizing score, mean (SD) | 13.6 units on a scale STANDARD_DEVIATION 10.7 | 13.5 units on a scale STANDARD_DEVIATION 10.7 | 13.6 units on a scale STANDARD_DEVIATION 11 |
| Partial mastectomy | 14 Participants | 4 Participants | 10 Participants |
| Partial mastectomy with axillary node dissection | 6 Participants | 4 Participants | 2 Participants |
| Partial mastectomy with sentinel node biopsy | 11 Participants | 7 Participants | 4 Participants |
| Partial mastectomy with sentinel node biopsy and reconstruction | 1 Participants | 0 Participants | 1 Participants |
| Peripheral nerve block | 11 Participants | 5 Participants | 6 Participants |
| Prerandomization perceptions of opioid-free analgesia: No specific expectation | 23 Participants | 14 Participants | 9 Participants |
| Prerandomization perceptions of opioid-free analgesia: Not effective | 2 Participants | 0 Participants | 2 Participants |
| Prerandomization perceptions of opioid-free analgesia: Somewhat Effective | 28 Participants | 17 Participants | 11 Participants |
| Prerandomization perceptions of opioid-free analgesia: Very Effective | 23 Participants | 8 Participants | 15 Participants |
| Prerandomization treatment group preference: Opioid-free medication group | 37 Participants | 19 Participants | 18 Participants |
| Prerandomization treatment group preference: Opioid medication group | 11 Participants | 7 Participants | 4 Participants |
| Prerandomization treatment group preference: Unsure or no preference | 28 Participants | 13 Participants | 15 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Received intraoperative regional analgesia | 57 Participants | 31 Participants | 26 Participants |
| Region of Enrollment Canada | 76 participants | 39 participants | 37 participants |
| Retired | 20 Participants | 9 Participants | 11 Participants |
| Risk of opioid abuse score ≥4 | 9 Participants | 4 Participants | 5 Participants |
| Risk of opioid abuse score (SD) | 1.9 units on a scale STANDARD_DEVIATION 1.6 | 2 units on a scale STANDARD_DEVIATION 1.6 | 1.8 units on a scale STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 50 Participants | 24 Participants | 26 Participants |
| Sex: Female, Male Male | 26 Participants | 15 Participants | 11 Participants |
| Student | 1 Participants | 0 Participants | 1 Participants |
| Total mastectomy with axillary node dissection and reconstruction | 1 Participants | 1 Participants | 0 Participants |
| Total mastectomy with sentinel node biopsy | 2 Participants | 2 Participants | 0 Participants |
| Total mastectomy with sentinel node biopsy and reconstruction | 1 Participants | 1 Participants | 0 Participants |
| Unable to work, receiving disability pension | 4 Participants | 3 Participants | 1 Participants |
| Unemployed | 5 Participants | 1 Participants | 4 Participants |
| Wound infiltration | 57 Participants | 31 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 37 |
| other Total, other adverse events | 14 / 39 | 16 / 37 |
| serious Total, serious adverse events | 1 / 39 | 1 / 37 |
Outcome results
Primary
Percentage of Eligible Patients Agreeing to Participate
At least 50% of eligible patients agree to participate in the study and are randomized.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Eligible Patients Agreeing to Participate | 93 Participants |
Primary
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).
Time frame: 4 months
Population: As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments | 33 Questionnaire Items |
Primary
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.
Time frame: 4 months
Population: As this is a feasibility trial, the feasibility outcomes were predetermined based on the protocol and were assessed and reported using the entire participant sample.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments | 37 Questionnaires |
Primary
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
At least 80% of the randomized patients complete outcome assessment at 30 days after surgery.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment | 39 Participants |
| Opioid-free Analgesia | Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment | 34 Participants |
Primary
Percentage of Randomized Patients Complying With Allocated Treatment
At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Randomized Patients Complying With Allocated Treatment | 39 Participants |
| Opioid-free Analgesia | Percentage of Randomized Patients Complying With Allocated Treatment | 36 Participants |
Primary
Percentage of Screened Participants Who Were Eligible to Participate in the Study
At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Screened Participants Who Were Eligible to Participate in the Study | 163 Participants |
Primary
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).
Time frame: 4 months
Population: \*Providers were not considered as enrolled participants but did contribute to this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Number of Screened Patients | Percentage of Surgeons Agreeing and Adhering to Patient Randomization | 15 Participants |
Secondary
Comprehensive Complication Index at 30-day
Measured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Number of Screened Patients | Comprehensive Complication Index at 30-day | 2.6 score on a scale | Standard Deviation 7.2 |
| Opioid-free Analgesia | Comprehensive Complication Index at 30-day | 0.9 score on a scale | Standard Deviation 4.5 |
Secondary
Opioid Side-effects
Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. The reported rates indicate the number of reported events per period of evaluation.
Time frame: Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Number of Screened Patients | Opioid Side-effects | Itching : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Itching : 30-day rate (any event) | 15 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Itching : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Inability to concentrate : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Difficulty with urination : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Confusion : 7-day rate (any event) | 2 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Fatigue : 7-day rate (clinically meaningful event) | 2 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Constipation : 7-day rate (any event) | 16 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Constipation : 7-day rate (clinically meaningful event) | 4 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Constipation : 30-day rate (any event) | 18 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Constipation : 30-day rate (clinically meaningful event) | 7 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Nausa : 7-day rate (any event) | 8 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Nausa : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Nausa : 30-day rate (any event) | 9 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Nausa : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Vomiting : 7-day rate (any event) | 3 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Vomiting : 7-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Vomiting : 30-day rate (any event) | 6 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Vomiting : 30-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Itching : 7-day rate (any event) | 13 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Fatigue : 7-day rate (any event) | 31 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Fatigue : 30-day rate (any event) | 32 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Fatigue : 30-day rate (clinically meaningful event) | 3 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Drowsiness : 7-day rate (any event) | 14 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Drowsiness : 7-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Drowsiness : 30-day rate (any event) | 14 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Drowsiness : 30-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Dizziness : 7-day rate (any event) | 7 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Dizziness : 7-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Dizziness : 30-day rate (any event) | 8 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Dizziness : 30-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Inability to concentrate : 7-day rate (any event) | 6 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Inability to concentrate : 30-day rate (any event) | 8 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Inability to concentrate : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Difficulty with urination : 7-day rate (any event) | 3 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Difficulty with urination : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Difficulty with urination : 30-day rate (any event) | 4 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Confusion : 7-day rate (clinically meaningful event) | 0 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Confusion : 30-day rate (any event) | 2 Number of reported events |
| Total Number of Screened Patients | Opioid Side-effects | Confusion : 30-day rate (clinically meaningful event) | 0 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Fatigue : 7-day rate (clinically meaningful event) | 5 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Itching : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Confusion : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Itching : 30-day rate (any event) | 15 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Fatigue : 30-day rate (any event) | 30 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Inability to concentrate : 7-day rate (any event) | 11 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Inability to concentrate : 7-day rate (clinically meaningful event) | 2 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Fatigue : 30-day rate (clinically meaningful event) | 11 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Difficulty with urination : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Confusion : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Drowsiness : 7-day rate (any event) | 13 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Inability to concentrate : 30-day rate (any event) | 11 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Constipation : 7-day rate (any event) | 12 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Drowsiness : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Constipation : 7-day rate (clinically meaningful event) | 2 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Difficulty with urination : 30-day rate (any event) | 4 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Constipation : 30-day rate (any event) | 15 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Drowsiness : 30-day rate (any event) | 13 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Constipation : 30-day rate (clinically meaningful event) | 3 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Inability to concentrate : 30-day rate (clinically meaningful event) | 2 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Nausa : 7-day rate (any event) | 6 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Drowsiness : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Nausa : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Confusion : 7-day rate (any event) | 3 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Nausa : 30-day rate (any event) | 8 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Dizziness : 7-day rate (any event) | 6 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Nausa : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Difficulty with urination : 7-day rate (any event) | 3 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Vomiting : 7-day rate (any event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Dizziness : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Vomiting : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Confusion : 30-day rate (any event) | 3 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Vomiting : 30-day rate (any event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Dizziness : 30-day rate (any event) | 7 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Vomiting : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Difficulty with urination : 7-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Itching : 7-day rate (any event) | 7 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Itching : 30-day rate (clinically meaningful event) | 2 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Dizziness : 30-day rate (clinically meaningful event) | 1 Number of reported events |
| Opioid-free Analgesia | Opioid Side-effects | Fatigue : 7-day rate (any event) | 28 Number of reported events |
Secondary
Postoperative Complications Classification
Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse). Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic
Time frame: 30 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Number of Screened Patients | Postoperative Complications Classification | I | 3 Participants |
| Total Number of Screened Patients | Postoperative Complications Classification | II | 2 Participants |
| Total Number of Screened Patients | Postoperative Complications Classification | IIIa/b | 1 Participants |
| Opioid-free Analgesia | Postoperative Complications Classification | I | 1 Participants |
| Opioid-free Analgesia | Postoperative Complications Classification | II | 0 Participants |
| Opioid-free Analgesia | Postoperative Complications Classification | IIIa/b | 1 Participants |
Secondary
Postoperative Health Status
Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured.
Time frame: Weeks 1, 2, 3 and 4 after surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Number of Screened Patients | Postoperative Health Status | Social participation POW 4 | 57.2 T-score | Standard Deviation 8.4 |
| Total Number of Screened Patients | Postoperative Health Status | Depression POW 3 | 44.7 T-score | Standard Deviation 6.4 |
| Total Number of Screened Patients | Postoperative Health Status | Physical functioning POW 4 | 52.1 T-score | Standard Deviation 7 |
| Total Number of Screened Patients | Postoperative Health Status | Depression POW 4 | 44.1 T-score | Standard Deviation 5.3 |
| Total Number of Screened Patients | Postoperative Health Status | Anxiety Baseline | 53.3 T-score | Standard Deviation 9.9 |
| Total Number of Screened Patients | Postoperative Health Status | Pain interference Baseline | 49.1 T-score | Standard Deviation 9 |
| Total Number of Screened Patients | Postoperative Health Status | Physical functioning POW 2 | 47.2 T-score | Standard Deviation 7.5 |
| Total Number of Screened Patients | Postoperative Health Status | Pain interference POW 1 | 55.7 T-score | Standard Deviation 8.3 |
| Total Number of Screened Patients | Postoperative Health Status | Anxiety POW 1 | 46.4 T-score | Standard Deviation 8.4 |
| Total Number of Screened Patients | Postoperative Health Status | Pain interference POW 2 | 50.5 T-score | Standard Deviation 8.9 |
| Total Number of Screened Patients | Postoperative Health Status | Social participation Baseline | 55 T-score | Standard Deviation 9.4 |
| Total Number of Screened Patients | Postoperative Health Status | POW 3 | 48.5 T-score | Standard Deviation 7.6 |
| Total Number of Screened Patients | Postoperative Health Status | Anxiety POW 2 | 45.9 T-score | Standard Deviation 8.1 |
| Total Number of Screened Patients | Postoperative Health Status | POW 4 | 45.9 T-score | Standard Deviation 6.8 |
| Total Number of Screened Patients | Postoperative Health Status | Physical functioning Post Operative Week (POW) 1 | 44.9 T-score | Standard Deviation 8.3 |
| Total Number of Screened Patients | Postoperative Health Status | Sleep disturbance Baseline | 46.8 T-score | Standard Deviation 9.8 |
| Total Number of Screened Patients | Postoperative Health Status | Anxiety POW 3 | 44.4 T-score | Standard Deviation 6.4 |
| Total Number of Screened Patients | Postoperative Health Status | Sleep disturbance POW 1 | 47.1 T-score | Standard Deviation 8.5 |
| Total Number of Screened Patients | Postoperative Health Status | Social participation POW 2 | 54.5 T-score | Standard Deviation 8.8 |
| Total Number of Screened Patients | Postoperative Health Status | Sleep disturbance POW 2 | 45.2 T-score | Standard Deviation 7.5 |
| Total Number of Screened Patients | Postoperative Health Status | Anxiety POW 4 | 44.5 T-score | Standard Deviation 6.7 |
| Total Number of Screened Patients | Postoperative Health Status | Sleep disturbance POW 3 | 45 T-score | Standard Deviation 8.3 |
| Total Number of Screened Patients | Postoperative Health Status | Physical functioning POW 3 | 49.6 T-score | Standard Deviation 7.7 |
| Total Number of Screened Patients | Postoperative Health Status | Sleep disturbance POW 4 | 43.6 T-score | Standard Deviation 8.5 |
| Total Number of Screened Patients | Postoperative Health Status | Depression Baseline | 47.1 T-score | Standard Deviation 8.7 |
| Total Number of Screened Patients | Postoperative Health Status | Fatigue Baseline | 45.9 T-score | Standard Deviation 9.5 |
| Total Number of Screened Patients | Postoperative Health Status | Social participation POW 3 | 56.5 T-score | Standard Deviation 8 |
| Total Number of Screened Patients | Postoperative Health Status | Fatigue POW 1 | 48.4 T-score | Standard Deviation 9.4 |
| Total Number of Screened Patients | Postoperative Health Status | Depression POW 1 | 45.6 T-score | Standard Deviation 6.8 |
| Total Number of Screened Patients | Postoperative Health Status | Fatigue POW 2 | 43 T-score | Standard Deviation 9.6 |
| Total Number of Screened Patients | Postoperative Health Status | Physical functioning Baseline | 50.2 T-score | Standard Deviation 8.3 |
| Total Number of Screened Patients | Postoperative Health Status | Fatigue POW 3 | 41.8 T-score | Standard Deviation 8.2 |
| Total Number of Screened Patients | Postoperative Health Status | Depression POW 2 | 45.1 T-score | Standard Deviation 6.7 |
| Total Number of Screened Patients | Postoperative Health Status | Fatigue POW 4 | 40.9 T-score | Standard Deviation 7.7 |
| Total Number of Screened Patients | Postoperative Health Status | Social participation POW 1 | 49.6 T-score | Standard Deviation 9.6 |
| Opioid-free Analgesia | Postoperative Health Status | Fatigue POW 4 | 42.2 T-score | Standard Deviation 9.8 |
| Opioid-free Analgesia | Postoperative Health Status | Social participation POW 1 | 47.3 T-score | Standard Deviation 10.4 |
| Opioid-free Analgesia | Postoperative Health Status | Physical functioning Baseline | 50.8 T-score | Standard Deviation 8.6 |
| Opioid-free Analgesia | Postoperative Health Status | Physical functioning Post Operative Week (POW) 1 | 44.1 T-score | Standard Deviation 9.1 |
| Opioid-free Analgesia | Postoperative Health Status | Physical functioning POW 2 | 47.9 T-score | Standard Deviation 8.1 |
| Opioid-free Analgesia | Postoperative Health Status | Physical functioning POW 3 | 50.6 T-score | Standard Deviation 7.3 |
| Opioid-free Analgesia | Postoperative Health Status | Physical functioning POW 4 | 51.5 T-score | Standard Deviation 7.2 |
| Opioid-free Analgesia | Postoperative Health Status | Social participation Baseline | 52.9 T-score | Standard Deviation 8.7 |
| Opioid-free Analgesia | Postoperative Health Status | Social participation POW 2 | 54.4 T-score | Standard Deviation 8.3 |
| Opioid-free Analgesia | Postoperative Health Status | Social participation POW 3 | 55.6 T-score | Standard Deviation 8.6 |
| Opioid-free Analgesia | Postoperative Health Status | Social participation POW 4 | 56.6 T-score | Standard Deviation 8.4 |
| Opioid-free Analgesia | Postoperative Health Status | Anxiety Baseline | 53 T-score | Standard Deviation 8.5 |
| Opioid-free Analgesia | Postoperative Health Status | Anxiety POW 1 | 48.6 T-score | Standard Deviation 8 |
| Opioid-free Analgesia | Postoperative Health Status | Anxiety POW 2 | 44.7 T-score | Standard Deviation 6.9 |
| Opioid-free Analgesia | Postoperative Health Status | Anxiety POW 3 | 43.2 T-score | Standard Deviation 5.6 |
| Opioid-free Analgesia | Postoperative Health Status | Anxiety POW 4 | 44.4 T-score | Standard Deviation 6.7 |
| Opioid-free Analgesia | Postoperative Health Status | Depression Baseline | 48 T-score | Standard Deviation 8.2 |
| Opioid-free Analgesia | Postoperative Health Status | Depression POW 1 | 46.2 T-score | Standard Deviation 7.2 |
| Opioid-free Analgesia | Postoperative Health Status | Depression POW 2 | 43.6 T-score | Standard Deviation 5.8 |
| Opioid-free Analgesia | Postoperative Health Status | Depression POW 3 | 43.7 T-score | Standard Deviation 5 |
| Opioid-free Analgesia | Postoperative Health Status | Depression POW 4 | 44.3 T-score | Standard Deviation 6 |
| Opioid-free Analgesia | Postoperative Health Status | Pain interference Baseline | 48.4 T-score | Standard Deviation 8.9 |
| Opioid-free Analgesia | Postoperative Health Status | Pain interference POW 1 | 55.5 T-score | Standard Deviation 9.1 |
| Opioid-free Analgesia | Postoperative Health Status | Pain interference POW 2 | 49.9 T-score | Standard Deviation 7.1 |
| Opioid-free Analgesia | Postoperative Health Status | POW 3 | 46.5 T-score | Standard Deviation 7.3 |
| Opioid-free Analgesia | Postoperative Health Status | POW 4 | 46.7 T-score | Standard Deviation 7.1 |
| Opioid-free Analgesia | Postoperative Health Status | Sleep disturbance Baseline | 49.3 T-score | Standard Deviation 8.6 |
| Opioid-free Analgesia | Postoperative Health Status | Sleep disturbance POW 1 | 47.4 T-score | Standard Deviation 9.1 |
| Opioid-free Analgesia | Postoperative Health Status | Sleep disturbance POW 2 | 46.9 T-score | Standard Deviation 9 |
| Opioid-free Analgesia | Postoperative Health Status | Sleep disturbance POW 3 | 46.1 T-score | Standard Deviation 9.3 |
| Opioid-free Analgesia | Postoperative Health Status | Sleep disturbance POW 4 | 44.3 T-score | Standard Deviation 9.3 |
| Opioid-free Analgesia | Postoperative Health Status | Fatigue Baseline | 47.7 T-score | Standard Deviation 10 |
| Opioid-free Analgesia | Postoperative Health Status | Fatigue POW 1 | 50.2 T-score | Standard Deviation 11.2 |
| Opioid-free Analgesia | Postoperative Health Status | Fatigue POW 2 | 44.6 T-score | Standard Deviation 10.3 |
| Opioid-free Analgesia | Postoperative Health Status | Fatigue POW 3 | 42.4 T-score | Standard Deviation 9.9 |
Secondary
Postoperative Pain
Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes.
Time frame: 30 days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Number of Screened Patients | Postoperative Pain | Baseline Interference Scale score | 0.9 score on a scale | Standard Deviation 1.9 |
| Total Number of Screened Patients | Postoperative Pain | POD6 Severity Scale score | 1.2 score on a scale | Standard Deviation 1.5 |
| Total Number of Screened Patients | Postoperative Pain | POD 1 Interference Scale score | 3 score on a scale | Standard Deviation 3.1 |
| Total Number of Screened Patients | Postoperative Pain | POD2 Severity Scale score | 2.7 score on a scale | Standard Deviation 2.3 |
| Total Number of Screened Patients | Postoperative Pain | POD 2 Interference Scale score | 2.4 score on a scale | Standard Deviation 2.5 |
| Total Number of Screened Patients | Postoperative Pain | POD7 Severity Scale score | 1.1 score on a scale | Standard Deviation 1.6 |
| Total Number of Screened Patients | Postoperative Pain | POD 3 Interference Scale score | 1.9 score on a scale | Standard Deviation 2.5 |
| Total Number of Screened Patients | Postoperative Pain | POD4 Severity Scale score | 1.6 score on a scale | Standard Deviation 1.7 |
| Total Number of Screened Patients | Postoperative Pain | POD 4 Interference Scale score | 1.6 score on a scale | Standard Deviation 2.6 |
| Total Number of Screened Patients | Postoperative Pain | Post Operative Week (POW) 2 Severity Scale score | 0.9 score on a scale | Standard Deviation 1.4 |
| Total Number of Screened Patients | Postoperative Pain | POD 5 Interference Scale score | 1.1 score on a scale | Standard Deviation 1.9 |
| Total Number of Screened Patients | Postoperative Pain | Post Operative Day (POD) 1 Severity Scale score | 2.8 score on a scale | Standard Deviation 2.2 |
| Total Number of Screened Patients | Postoperative Pain | POD 6 Interference Scale score | 1.2 score on a scale | Standard Deviation 2 |
| Total Number of Screened Patients | Postoperative Pain | POW3 Severity Scale score | 0.5 score on a scale | Standard Deviation 1 |
| Total Number of Screened Patients | Postoperative Pain | POD 7 Interference Scale score | 1.1 score on a scale | Standard Deviation 2 |
| Total Number of Screened Patients | Postoperative Pain | POD5 Severity Scale score | 1.3 score on a scale | Standard Deviation 1.7 |
| Total Number of Screened Patients | Postoperative Pain | POW 2 Interference Scale score | 1 score on a scale | Standard Deviation 1.7 |
| Total Number of Screened Patients | Postoperative Pain | POW4 Severity Scale score | 0.5 score on a scale | Standard Deviation 1.3 |
| Total Number of Screened Patients | Postoperative Pain | POW 3 Interference Scale score | 0.6 score on a scale | Standard Deviation 1.5 |
| Total Number of Screened Patients | Postoperative Pain | POD3 Severity Scale score | 2.1 score on a scale | Standard Deviation 2 |
| Total Number of Screened Patients | Postoperative Pain | POW 4 Interference Scale score | 0.2 score on a scale | Standard Deviation 0.6 |
| Total Number of Screened Patients | Postoperative Pain | Baseline Severity Scale score | 0.9 score on a scale | Standard Deviation 1.7 |
| Opioid-free Analgesia | Postoperative Pain | POW 4 Interference Scale score | 0.1 score on a scale | Standard Deviation 0.6 |
| Opioid-free Analgesia | Postoperative Pain | Baseline Severity Scale score | 1 score on a scale | Standard Deviation 2 |
| Opioid-free Analgesia | Postoperative Pain | Post Operative Day (POD) 1 Severity Scale score | 3 score on a scale | Standard Deviation 1.7 |
| Opioid-free Analgesia | Postoperative Pain | POD2 Severity Scale score | 2.6 score on a scale | Standard Deviation 2.1 |
| Opioid-free Analgesia | Postoperative Pain | POD3 Severity Scale score | 1.7 score on a scale | Standard Deviation 1.8 |
| Opioid-free Analgesia | Postoperative Pain | POD4 Severity Scale score | 1.4 score on a scale | Standard Deviation 1.7 |
| Opioid-free Analgesia | Postoperative Pain | POD5 Severity Scale score | 1.1 score on a scale | Standard Deviation 1.3 |
| Opioid-free Analgesia | Postoperative Pain | POD6 Severity Scale score | 1.1 score on a scale | Standard Deviation 1.4 |
| Opioid-free Analgesia | Postoperative Pain | POD7 Severity Scale score | 0.9 score on a scale | Standard Deviation 1.2 |
| Opioid-free Analgesia | Postoperative Pain | Post Operative Week (POW) 2 Severity Scale score | 0.4 score on a scale | Standard Deviation 0.8 |
| Opioid-free Analgesia | Postoperative Pain | POW3 Severity Scale score | 0.4 score on a scale | Standard Deviation 0.8 |
| Opioid-free Analgesia | Postoperative Pain | POW4 Severity Scale score | 0.3 score on a scale | Standard Deviation 0.8 |
| Opioid-free Analgesia | Postoperative Pain | Baseline Interference Scale score | 0.7 score on a scale | Standard Deviation 1.7 |
| Opioid-free Analgesia | Postoperative Pain | POD 1 Interference Scale score | 3.3 score on a scale | Standard Deviation 2.1 |
| Opioid-free Analgesia | Postoperative Pain | POD 2 Interference Scale score | 2.3 score on a scale | Standard Deviation 2 |
| Opioid-free Analgesia | Postoperative Pain | POD 3 Interference Scale score | 1.8 score on a scale | Standard Deviation 1.9 |
| Opioid-free Analgesia | Postoperative Pain | POD 4 Interference Scale score | 1.4 score on a scale | Standard Deviation 1.9 |
| Opioid-free Analgesia | Postoperative Pain | POD 5 Interference Scale score | 1 score on a scale | Standard Deviation 1.7 |
| Opioid-free Analgesia | Postoperative Pain | POD 6 Interference Scale score | 0.8 score on a scale | Standard Deviation 1.5 |
| Opioid-free Analgesia | Postoperative Pain | POD 7 Interference Scale score | 1 score on a scale | Standard Deviation 1.9 |
| Opioid-free Analgesia | Postoperative Pain | POW 2 Interference Scale score | 0.5 score on a scale | Standard Deviation 1.5 |
| Opioid-free Analgesia | Postoperative Pain | POW 3 Interference Scale score | 0.4 score on a scale | Standard Deviation 1.2 |
Secondary
Rate of Adverse Drug Events
Obtained from spontaneous patient reporting (Trigger question Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system.
Time frame: 30 days after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Number of Screened Patients | Rate of Adverse Drug Events | Productive cough | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Postoperative wound infection | 2 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Dyspepsia | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Oropharyngeal pain | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Ecchymosis | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Cough | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Hypoesthesia | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Abdominal distention | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Neuralgia | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Urinary retention | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Penile swelling | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Testicular swelling | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Hypertention | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Seroma | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Breast haematoma | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Urinary tract infection | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Tachycardia | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Cystitis | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Diarrhea | 1 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Peripheral neuropathy | 0 Participants |
| Total Number of Screened Patients | Rate of Adverse Drug Events | Headache | 4 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Peripheral neuropathy | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Headache | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Diarrhea | 2 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Tachycardia | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Oropharyngeal pain | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Abdominal distention | 3 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Postoperative wound infection | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Cough | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Urinary retention | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Hypertention | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Breast haematoma | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Productive cough | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Dyspepsia | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Ecchymosis | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Hypoesthesia | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Neuralgia | 0 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Penile swelling | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Testicular swelling | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Seroma | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Urinary tract infection | 1 Participants |
| Opioid-free Analgesia | Rate of Adverse Drug Events | Cystitis | 1 Participants |
Secondary
Rate of Opioid Misuse
Measured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to \>1 question indicates the patient exhibits prescription opioid misuse.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Number of Screened Patients | Rate of Opioid Misuse | 0.1 score on a scale | Standard Deviation 0.4 |
| Opioid-free Analgesia | Rate of Opioid Misuse | 0.1 score on a scale | Standard Deviation 4 |
Secondary
Rate of Prolonged Opioid Use
Filling of opioid prescriptions up to 3 months after surgery.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | POM 2 | 0 Participants |
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | POW 2 | 0 Participants |
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | POM 3 | 1 Participants |
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | POW 3 | 0 Participants |
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | Post Operative Week (POW) 1 | 25 Participants |
| Total Number of Screened Patients | Rate of Prolonged Opioid Use | POW 4 | 0 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | POM 3 | 2 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | POW 4 | 0 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | POM 2 | 1 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | Post Operative Week (POW) 1 | 1 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | POW 2 | 0 Participants |
| Opioid-free Analgesia | Rate of Prolonged Opioid Use | POW 3 | 0 Participants |
Secondary
Rate of Unplanned Healthcare Utilization
Emergency department visits, hospital readmissions.
Time frame: 30 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Number of Screened Patients | Rate of Unplanned Healthcare Utilization | Readmission | 1 Participants |
| Total Number of Screened Patients | Rate of Unplanned Healthcare Utilization | Any | 6 Participants |
| Total Number of Screened Patients | Rate of Unplanned Healthcare Utilization | Outpatient clinic visit | 2 Participants |
| Total Number of Screened Patients | Rate of Unplanned Healthcare Utilization | ED visit | 5 Participants |
| Opioid-free Analgesia | Rate of Unplanned Healthcare Utilization | Outpatient clinic visit | 0 Participants |
| Opioid-free Analgesia | Rate of Unplanned Healthcare Utilization | Readmission | 1 Participants |
| Opioid-free Analgesia | Rate of Unplanned Healthcare Utilization | ED visit | 0 Participants |
| Opioid-free Analgesia | Rate of Unplanned Healthcare Utilization | Any | 1 Participants |
Secondary
Time to Stopping Pain Medication
The time to the first report of stopping the use of pain medication.
Time frame: 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Number of Screened Patients | Time to Stopping Pain Medication | 9 days postoperative | Standard Deviation 9 |
| Opioid-free Analgesia | Time to Stopping Pain Medication | 9 days postoperative | Standard Deviation 7.9 |