Postoperative Pain
Conditions
Keywords
Mastectomy
Brief summary
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy. The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.
Interventions
DRUGKetamine
Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.
DRUGPlacebo
Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adult women, aged 18 to 80 years old, who will undergo mastectomy. 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction 4. No distant metastases. 5. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3. 6. Subject is medically stable.
Exclusion criteria
1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety. 2. Past ketamine or phencyclidine misuse or abuse. 3. Schizophrenia or history of psychosis. 4. Known sensitivity or allergy to ketamine. 5. Liver or renal insufficiency. 6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated 7. Pregnancy or nursing women 8. BMI\>35. 9. Currently participating in another pain interventional trial. 10. Unwillingness to give informed consent. 11. Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 24 Hours Post-Op (Day 2) | BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | Baseline (Day 0) | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. |
| Total Dosage of Opioid Use | Day of Surgery (Day 1) | Use and dosage will be assessed through medical records and subject reports. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | Baseline (Day 0) | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | Baseline (Day 0) | The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. |
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | Baseline (Day 0) | BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. |
| Breast Cancer Pain Questionnaire (BCPQ) - Pain Score | Day 7 Post-Op (Day 8) | If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. The total score is the sum of responses from each location. |
| Quality of Recovery (QoR-15) Survey Score | Day 2 Post-Op (Day 3) | Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Total scores range from 0-150; the higher the score, the better the participant has been feeling. |
| Number of Participants Who Experience Side Effects | Day of Surgery (Day 1) | Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects of ketamine. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events. |
| Generalized Anxiety Disorder (GAD-2) Score | Baseline (Day 0) | GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Ketamine: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. | 15 |
| Control Placebo: Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 48.9 years | 47.3 years | 46.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.
Time frame: 48 Hours Post-Op (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 16 score on a scale | Standard Deviation 5.32 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 15.7 score on a scale | Standard Deviation 9.36 |
Primary
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.
Time frame: 24 Hours Post-Op (Day 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 16.7 score on a scale | Standard Deviation 6.97 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 18.1 score on a scale | Standard Deviation 8.44 |
Secondary
Breast Cancer Pain Questionnaire (BCPQ) - Pain Score
If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. The total score is the sum of responses from each location.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Breast Cancer Pain Questionnaire (BCPQ) - Pain Score | 3.53 score on a scale | Standard Deviation 2.56 |
| Control | Breast Cancer Pain Questionnaire (BCPQ) - Pain Score | 4.6 score on a scale | Standard Deviation 2.72 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.
Time frame: Day 2 Post-Op (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 33.5 score on a scale | Standard Deviation 12.5 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 32.1 score on a scale | Standard Deviation 15.5 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 33.9 score on a scale | Standard Deviation 18.3 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 32.9 score on a scale | Standard Deviation 15.1 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.
Time frame: Baseline (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 35 score on a scale | Standard Deviation 18.29 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 35 score on a scale | Standard Deviation 30.35 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference.
Time frame: Day 1 Post-Op (Day 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 24.7 score on a scale | Standard Deviation 17.1 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | 28.1 score on a scale | Standard Deviation 14.9 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 11.5 score on a scale | Standard Deviation 6.17 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 15 score on a scale | Standard Deviation 8.68 |
Secondary
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain.
Time frame: Baseline (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 3.5 score on a scale | Standard Deviation 6.45 |
| Control | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | 2.2 score on a scale | Standard Deviation 5.37 |
Secondary
Generalized Anxiety Disorder (GAD-2) Score
GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Generalized Anxiety Disorder (GAD-2) Score | 2.13 score on a scale | Standard Deviation 1.73 |
| Control | Generalized Anxiety Disorder (GAD-2) Score | 1.13 score on a scale | Standard Deviation 1.51 |
Secondary
Generalized Anxiety Disorder (GAD-2) Score
GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety.
Time frame: Baseline (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Generalized Anxiety Disorder (GAD-2) Score | 2.47 score on a scale | Standard Deviation 1.77 |
| Control | Generalized Anxiety Disorder (GAD-2) Score | 1.87 score on a scale | Standard Deviation 2.07 |
Secondary
Number of Participants Who Experience Side Effects
Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events.
Time frame: Day 1 Post-Op (Day 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Experience Side Effects | 8 Participants |
| Control | Number of Participants Who Experience Side Effects | 5 Participants |
Secondary
Number of Participants Who Experience Side Effects
Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects of ketamine. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events.
Time frame: Day of Surgery (Day 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Experience Side Effects | 7 Participants |
| Control | Number of Participants Who Experience Side Effects | 7 Participants |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.
Time frame: Day 1 Post-Op (Day 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 52.3 T-score | Standard Deviation 13.1 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 53.6 T-score | Standard Deviation 10.5 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.
Time frame: Day 2 Post-Op (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 56.6 T-score | Standard Deviation 7.07 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 54 T-score | Standard Deviation 7.71 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 49.1 T-score | Standard Deviation 10.6 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 50.4 T-score | Standard Deviation 10.8 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue.
Time frame: Baseline (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 46.7 T-score | Standard Deviation 12.5 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | 44.5 T-score | Standard Deviation 9.51 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | 51.7 T-score | Standard Deviation 9.19 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | 50.7 T-score | Standard Deviation 9.2 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance.
Time frame: Baseline (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | 53.6 T-score | Standard Deviation 5.39 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | 49.2 T-score | Standard Deviation 10.1 |
Secondary
Quality of Recovery (QoR-15) Survey Score
Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Total scores range from 0-150; the higher the score, the better the participant has been feeling.
Time frame: Day 2 Post-Op (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Quality of Recovery (QoR-15) Survey Score | 75.1 score on a scale | Standard Deviation 12 |
| Control | Quality of Recovery (QoR-15) Survey Score | 74.6 score on a scale | Standard Deviation 13.2 |
Secondary
Quality of Recovery (QoR-15) Survey Score
Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Quality of Recovery (QoR-15) Survey Score | 81.6 score on a scale | Standard Deviation 18.4 |
| Control | Quality of Recovery (QoR-15) Survey Score | 80.4 score on a scale | Standard Deviation 11.5 |
Secondary
Total Dosage of Opioid Use
Use and dosage will be assess through medical records and subject reports.
Time frame: Day 2 Post-Op (Day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Dosage of Opioid Use | 21.2 oral morphine equivalent (mg) | Standard Deviation 31.1 |
| Control | Total Dosage of Opioid Use | 18.5 oral morphine equivalent (mg) | Standard Deviation 21.2 |
Secondary
Total Dosage of Opioid Use
Use and dosage will be assessed through medical records and subject reports.
Time frame: Day 1 Post-Op (Day 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Dosage of Opioid Use | 21.5 oral morphine equivalent (mg) | Standard Deviation 17.9 |
| Control | Total Dosage of Opioid Use | 37.2 oral morphine equivalent (mg) | Standard Deviation 61.4 |
Secondary
Total Dosage of Opioid Use
Use and dosage will be assessed through medical records and subject reports.
Time frame: Day of Surgery (Day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Dosage of Opioid Use | 6 oral morphine equivalent (mg) | Standard Deviation 7.06 |
| Control | Total Dosage of Opioid Use | 5 oral morphine equivalent (mg) | Standard Deviation 6.61 |
Secondary
Total Dosage of Opioid Use
Use and dosage will be assess through medical records and subject reports.
Time frame: Day 7 Post-Op (Day 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Dosage of Opioid Use | 0.833 oral morphine equivalent (mg) | Standard Deviation 2.25 |
| Control | Total Dosage of Opioid Use | 7 oral morphine equivalent (mg) | Standard Deviation 2.25 |