Posterior Spine Surgery
Conditions
Brief summary
Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery
Detailed description
This is a randomized controlled trial comparing spine surgery analgesic pathway with usual care in improving postoperative quality of recovery and pain management in spine surgery patients. At the time of surgery office visit or at the time of preoperative assessment by anesthesia care team, risk factor for suboptimal pain management will be identified and documented. Patients will be assessed at the time for surgical office visit for their risk for severe post-operative pain. Patients with 2 or more risk factors will be classified as high-risk for severe postoperative pain and the patients with less than 2 factors as low risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one of the 2 study groups on the day of the surgery: 1. Usual care group A 2. Care pathway group B If the participant is randomized to the spine surgery analgesic pathway group the participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery for their specific pain management needs. The participant will also get some additional medication for pain in preoperative and intraoperative period. Before surgery the participant will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is asleep the participant will receive an infusion of ketamine and lidocaine through the participant venous line. After the surgery the participant will receive pain medications as per current standard protocol including acetaminophen and gabapentin. Pain management team specialist will follow for pain control after a surgery as needed. If the participant is randomized to the usual care group the participant will be given placebo preoperatively; the rest of the time pain medication will be provided in a routine manner as per the anesthesia care team and the surgical team. Pain management team specialist will follow for pain control after a surgery as needed. The primary outcome will be assessed on post-operative day 3: The participants will complete a short survey about quality of recovery.
Interventions
OTHERSpine surgery analgesic pathway
Enhanced pain management care
OTHERUsual Care
Standard of pain management care
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients. * Posterior spine surgery * Surgery performed at Cleveland Clinic main campus
Exclusion criteria
* Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin * Current or recent drug abuse (within past 6 months) * Pregnancy * Immune system disease such as HIV, AIDS * Undergoing immunosuppressive treatment * Recent history of sepsis * Contraindications to lidocaine such as heart block and hepatic insufficiency * Heart failure with ejection fraction less than 30% * Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | Three days after surgery | Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient how have you been feeling during the past 24 hours. Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization | up to 48 hours | Opioid consumption within the initial 48 h was converted to IV morphine equivalents using the conversions specified in Supplemental Digital Content 1 (http:// links.lww.com/ALN/C178). |
| Time-weighted Pain Score | 15-min interval after surgery until postoperative 2 days or discharge, whichever came first | Postoperative pain was evaluated with numeric rating scores (0-10) at 15-min intervals for the initial two postoperative hours or until discharge, whichever came first. A time-weighted averages pain score is equal to the sum of the portion of each time interval (as a decimal, such as 0.25h) multiplied by the levels of the pain (0-10 numeric rating scores) during the time period divided by 48h. |
| Opioid-related Side Effects Score POD1 (Postoperative Day 1) | POD1 | Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects. |
| Opioid-related Side Effects Score POD2 (Postoperative Day 2) | POD2 | Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome: PACU Length of Stay (h) | from the time when patients were transferred to the Post-Anesthesia Care Unit to the time when patients were transferred out from the Post-Anesthesia Care Unit. | Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU. |
| Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | postoperative time until discharge | Postoperative nausea and vomiting was assessed using Postoperative Nursing Progress Record (NPR) - Records nausea vomiting severity as 0=none, 1= mild, 2=moderate, 3= severe. |
| Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100) | POD 3 (72 hours) or discharge, whichever comes earlier | The patient satisfaction with pain management at discharge using (NRS 1-100) or on POD 3 or discharge, whichever comes earlier. The higher score means a better outcome |
| Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need | postoperative until discharge | The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need |
| Exploratory Outcome: Postoperative Length of Hospital Stay (Days) | postoperative time until discharge | Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery. |
| Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months | At 1 months | Quality of postoperative recovery will be assessed by asking the patient how have you been feeling during the past 24 hours. Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery. |
| Exploratory to Measure PDQ (Pain Disability) Using EQ-5D | Up to 3 months | Using EQ-5D questionnaire for pain disability measurements, at 3 months with the flexibility of +/- 5 days using the EQ-5D questionnaire (0) no pain to (10) worst pain. EQ-5D is a standardized measure of health status developed by EuroQol GROUP |
| Exploratory to Measure Health-related Quality of Life Using EQ-5D | baseline | It is one of several instruments used to verify the quality-adjusted life years associated with a health state. It is defined as a survey instrument for measuring economic preferences for health states based on the assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 items in total). Each dimension has 3 levels: 1=no problem, 2=moderate problem, 3=severe problem. The total scores are calculated for each subject. |
| Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale) | at 3 months | The exploratory outcome chronic postsurgical pain at 3 months was assessed by phone call using a numeric rating scale (0 to 10) where a score of 0 is no pain and a score of 10 is pain as bad as it could be. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spine Surgery Analgesic Pathway Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).
During surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).
After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.
Spine surgery analgesic pathway: Enhanced pain management care | 150 |
| Usual Care Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).
Placebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).
After surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.
Usual Care: Standard of pain management care | 149 |
| Total | 299 |
Baseline characteristics
| Characteristic | Spine Surgery Analgesic Pathway | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 11 |
| ASA status, No (%) I | 1 Participants | 3 Participants | 2 Participants |
| ASA status, No (%) II | 32 Participants | 53 Participants | 21 Participants |
| ASA status, No (%) III | 117 Participants | 243 Participants | 126 Participants |
| BMI | 31 kg/m^2 STANDARD_DEVIATION 7 | 31 kg/m^2 STANDARD_DEVIATION 7 | 32 kg/m^2 STANDARD_DEVIATION 7 |
| Charlson comorbidity index, No(%) 0 | 80 Participants | 163 Participants | 83 Participants |
| Charlson comorbidity index, No(%) 1 | 36 Participants | 70 Participants | 34 Participants |
| Charlson comorbidity index, No(%) 2 | 21 Participants | 41 Participants | 20 Participants |
| Charlson comorbidity index, No(%) 3 | 4 Participants | 11 Participants | 7 Participants |
| Charlson comorbidity index, No(%) 4 and above | 9 Participants | 14 Participants | 5 Participants |
| High anxiety before surgery | 54 Participants | 108 Participants | 54 Participants |
| History of chronic pain | 120 Participants | 228 Participants | 108 Participants |
| History of diabetes | 33 Participants | 58 Participants | 25 Participants |
| No. of risk factors for uncontrolled postoperative pain 1 | 3 Participants | 3 Participants | 0 Participants |
| No. of risk factors for uncontrolled postoperative pain 2 | 40 Participants | 80 Participants | 40 Participants |
| No. of risk factors for uncontrolled postoperative pain 3 | 44 Participants | 86 Participants | 42 Participants |
| No. of risk factors for uncontrolled postoperative pain 4 | 32 Participants | 79 Participants | 47 Participants |
| No. of risk factors for uncontrolled postoperative pain 5 | 26 Participants | 44 Participants | 18 Participants |
| No. of risk factors for uncontrolled postoperative pain 6 | 5 Participants | 7 Participants | 2 Participants |
| Preoperative pain score | 5.3 units on a scale STANDARD_DEVIATION 2.8 | 5.3 units on a scale STANDARD_DEVIATION 2.8 | 5.3 units on a scale STANDARD_DEVIATION 2.7 |
| Previous opioid use | 80 Participants | 161 Participants | 81 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 144 Participants | 284 Participants | 140 Participants |
| Sex: Female, Male Female | 69 Participants | 147 Participants | 78 Participants |
| Sex: Female, Male Male | 81 Participants | 152 Participants | 71 Participants |
| Smoking | 71 Participants | 144 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 149 |
| other Total, other adverse events | 0 / 150 | 0 / 149 |
| serious Total, serious adverse events | 0 / 150 | 0 / 149 |
Outcome results
Primary
Quality of Recovery
Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient how have you been feeling during the past 24 hours. Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.
Time frame: Three days after surgery
Population: 21 patients in the treatment group were missing and 20 patients were missing in the placebo group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Quality of Recovery | 109 units on a scale | Standard Deviation 25 |
| Usual Care | Quality of Recovery | 109 units on a scale | Standard Deviation 23 |
p-value: 0.9295% CI: [-6, 6]t-test, 2 sided
Secondary
Opioid-related Side Effects Score POD1 (Postoperative Day 1)
Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.
Time frame: POD1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Opioid-related Side Effects Score POD1 (Postoperative Day 1) | 2 score on a scale |
| Usual Care | Opioid-related Side Effects Score POD1 (Postoperative Day 1) | 2 score on a scale |
Secondary
Opioid-related Side Effects Score POD2 (Postoperative Day 2)
Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.
Time frame: POD2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Opioid-related Side Effects Score POD2 (Postoperative Day 2) | 2 score on a scale |
| Usual Care | Opioid-related Side Effects Score POD2 (Postoperative Day 2) | 2 score on a scale |
Secondary
Opioid Utilization
Opioid consumption within the initial 48 h was converted to IV morphine equivalents using the conversions specified in Supplemental Digital Content 1 (http:// links.lww.com/ALN/C178).
Time frame: up to 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Opioid Utilization | 72 mg |
| Usual Care | Opioid Utilization | 75 mg |
p-value: <0.00195% CI: [-21, 3]Hodges-Lehmann estimator
p-value: 0.17597.5% CI: [-23, 5]Hodges-Lehmann estimator
Secondary
Time-weighted Pain Score
Postoperative pain was evaluated with numeric rating scores (0-10) at 15-min intervals for the initial two postoperative hours or until discharge, whichever came first. A time-weighted averages pain score is equal to the sum of the portion of each time interval (as a decimal, such as 0.25h) multiplied by the levels of the pain (0-10 numeric rating scores) during the time period divided by 48h.
Time frame: 15-min interval after surgery until postoperative 2 days or discharge, whichever came first
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Time-weighted Pain Score | 4.8 units on a scale | Standard Error 1.8 |
| Usual Care | Time-weighted Pain Score | 5.2 units on a scale | Standard Error 1.9 |
p-value: <0.00195% CI: [-0.8, 1]Regression, Linear
p-value: 0.09497.5% CI: [-0.8, 0.1]Regression, Linear
Other Pre-specified
Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)
The exploratory outcome chronic postsurgical pain at 3 months was assessed by phone call using a numeric rating scale (0 to 10) where a score of 0 is no pain and a score of 10 is pain as bad as it could be.
Time frame: at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale) | 2.6 units on a scale | Standard Deviation 0.5 |
| Usual Care | Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale) | 2.9 units on a scale | Standard Deviation 2.9 |
Other Pre-specified
Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)
The patient satisfaction with pain management at discharge using (NRS 1-100) or on POD 3 or discharge, whichever comes earlier. The higher score means a better outcome
Time frame: POD 3 (72 hours) or discharge, whichever comes earlier
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100) | 78 units on a scale | Standard Deviation 22 |
| Usual Care | Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100) | 81 units on a scale | Standard Deviation 20 |
Other Pre-specified
Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months
Quality of postoperative recovery will be assessed by asking the patient how have you been feeling during the past 24 hours. Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.
Time frame: At 1 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months | 125 units on a scale | Standard Deviation 22 |
| Usual Care | Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months | 122 units on a scale | Standard Deviation 20 |
Other Pre-specified
Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need
The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need
Time frame: postoperative until discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need | 16 Participants |
| Usual Care | Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need | 13 Participants |
Post Hoc
Exploratory Outcome: Number of Participants With Postoperative Acetaminophen Use
This outcome measured how many patients used acetaminophen during the 48 hours after the surgery
Time frame: 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Number of Participants With Postoperative Acetaminophen Use | 141 Participants |
| Usual Care | Exploratory Outcome: Number of Participants With Postoperative Acetaminophen Use | 136 Participants |
Other Pre-specified
Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU
Postoperative nausea and vomiting was assessed using Postoperative Nursing Progress Record (NPR) - Records nausea vomiting severity as 0=none, 1= mild, 2=moderate, 3= severe.
Time frame: postoperative time until discharge
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | None | 91 Participants |
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Mild | 27 Participants |
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Moderate | 15 Participants |
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Severe | 13 Participants |
| Usual Care | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Severe | 10 Participants |
| Usual Care | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | None | 95 Participants |
| Usual Care | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Moderate | 12 Participants |
| Usual Care | Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU | Mild | 30 Participants |
Other Pre-specified
Exploratory Outcome: PACU Length of Stay (h)
Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU.
Time frame: from the time when patients were transferred to the Post-Anesthesia Care Unit to the time when patients were transferred out from the Post-Anesthesia Care Unit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: PACU Length of Stay (h) | 3.6 hours |
| Usual Care | Exploratory Outcome: PACU Length of Stay (h) | 3.3 hours |
Other Pre-specified
Exploratory Outcome: Postoperative Length of Hospital Stay (Days)
Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery.
Time frame: postoperative time until discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: Postoperative Length of Hospital Stay (Days) | 3 days |
| Usual Care | Exploratory Outcome: Postoperative Length of Hospital Stay (Days) | 4 days |
Post Hoc
Exploratory Outcome: the Number of Patients Who Had Postoperative Gabapentin
This outcome measured how many patients used postoperative gabapentin during the 48 hours after the surgery.
Time frame: 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: the Number of Patients Who Had Postoperative Gabapentin | 59 Participants |
| Usual Care | Exploratory Outcome: the Number of Patients Who Had Postoperative Gabapentin | 59 Participants |
Post Hoc
Exploratory Outcome: the Number of Patients Who Had Postoperative Ketorolac Within 48 Hours
This outcome measured how many patients used postoperative ketorolac during the 48 hours after the surgery.
Time frame: within 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: the Number of Patients Who Had Postoperative Ketorolac Within 48 Hours | 38 Participants |
| Usual Care | Exploratory Outcome: the Number of Patients Who Had Postoperative Ketorolac Within 48 Hours | 38 Participants |
Post Hoc
Exploratory Outcome: the Number of Patients Who Had Postoperative PCA (Patient-controlled Analgesia) Use Within 48h
This outcome measured how many patients used postoperative patient-controlled analgesia during the 48 hours after the surgery.
Time frame: within 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: the Number of Patients Who Had Postoperative PCA (Patient-controlled Analgesia) Use Within 48h | 90 Participants |
| Usual Care | Exploratory Outcome: the Number of Patients Who Had Postoperative PCA (Patient-controlled Analgesia) Use Within 48h | 81 Participants |
Post Hoc
Exploratory Outcome: the Number of Patients Who Had Postoperative Suboxone Within 48 Hours
This outcome measured how many patients used postoperative suboxone during the 48 hours after the surgery.
Time frame: within 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: the Number of Patients Who Had Postoperative Suboxone Within 48 Hours | 0 Participants |
| Usual Care | Exploratory Outcome: the Number of Patients Who Had Postoperative Suboxone Within 48 Hours | 0 Participants |
Post Hoc
Exploratory Outcome: the Number of Patients Who Had Postoperative Tramadol
This outcome measured how many patients used postoperative tramadol during the 48 hours after the surgery.
Time frame: 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory Outcome: the Number of Patients Who Had Postoperative Tramadol | 1 Participants |
| Usual Care | Exploratory Outcome: the Number of Patients Who Had Postoperative Tramadol | 7 Participants |
Other Pre-specified
Exploratory to Measure Health-related Quality of Life Using EQ-5D
It is one of several instruments used to verify the quality-adjusted life years associated with a health state. It is defined as a survey instrument for measuring economic preferences for health states based on the assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 items in total). Each dimension has 3 levels: 1=no problem, 2=moderate problem, 3=severe problem. The total scores are calculated for each subject.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory to Measure Health-related Quality of Life Using EQ-5D | 8.6 units on a scale | Standard Deviation 2 |
| Usual Care | Exploratory to Measure Health-related Quality of Life Using EQ-5D | 9.1 units on a scale | Standard Deviation 2.4 |
Other Pre-specified
Exploratory to Measure PDQ (Pain Disability) Using EQ-5D
Using EQ-5D questionnaire for pain disability measurements, at 3 months with the flexibility of +/- 5 days using the EQ-5D questionnaire (0) no pain to (10) worst pain. EQ-5D is a standardized measure of health status developed by EuroQol GROUP
Time frame: Up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Exploratory to Measure PDQ (Pain Disability) Using EQ-5D | 7.0 units on a scale | Standard Deviation 2 |
| Usual Care | Exploratory to Measure PDQ (Pain Disability) Using EQ-5D | 7.3 units on a scale | Standard Deviation 2.1 |
Post Hoc
Secondary Outcome: 24-h Opioid Consumption
This outcome measured how many postoperative opioids (mg in morphine equivalents) patients used during the 24 hours after the surgery.
Time frame: within 24 hours after the surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spine Surgery Analgesic Pathway | Secondary Outcome: 24-h Opioid Consumption | 47 mg |
| Usual Care | Secondary Outcome: 24-h Opioid Consumption | 45 mg |
p-value: <0.00195% CI: [-0.3, 0.1]Wilcoxon (Mann-Whitney)
p-value: 0.17197.5% CI: [-0.3, 0.1]Wilcoxon sum rank test
Post Hoc
Secondary Outcome: 24h Time-weighted Average Pain Score
Pain score is a 10 point scale score where the higher means more pain.
Time frame: within 24 hours after the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spine Surgery Analgesic Pathway | Secondary Outcome: 24h Time-weighted Average Pain Score | 4.8 score on a scale | Standard Deviation 1.9 |
| Usual Care | Secondary Outcome: 24h Time-weighted Average Pain Score | 5.3 score on a scale | Standard Deviation 2 |
p-value: <0.00195% CI: [-1, -0.1]Regression, Linear
p-value: 0.02597.5% CI: [-1, 0]Regression, Linear