Lumbar Radiculopathy
Conditions
Brief summary
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.
Detailed description
This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include: The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine The secondary objectives include: Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively. Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.
Interventions
DRUGLiposomal bupivacaine
liposomal bupivacaine
DRUGBupivacaine
bupivacaine 0.25% in ESP blocks
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged greater than or equal to 18 years old and less than or equal to 85 years old. * Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.
Exclusion criteria
* Patients with a history of chronic opioid use for \> 3 months including but not limited to fentanyl, morphine, oxycodone, methadone. * Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications. * Patients with a history of alcohol or drug abuse. * Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency. * Patients with renal insufficiency. * Patients who are pregnant. * Patients with American Society of Anesthesiologists physical status of 4 or greater. * Patients on immunosuppressive therapy. Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption During First 72 Hours | 12 hours, 24 hours, 48 hours, 72 hours | The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | up to 12 weeks | Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain. |
| Quality of Recovery (QOR 15) | 72 hours | Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome. |
| Number of Participants With Postoperative Nausea/Vomiting (PONV) | in PACU (4 hours) | Number of participants with postoperative nausea/vomiting (PONV) in PACU |
| Time to Ambulation | average 26-27 hours | Time to ambulation in hours |
| Hospital Length of Stay | average 72 hours | Hospital length of stay (LOS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Only Bupivacaine: bupivacaine 0.25% in ESP blocks | 5 |
| Liposomal Bupivacaine and Bupivacaine Liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Bupivacaine Only | Liposomal Bupivacaine and Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 13.35 | 63.3 years STANDARD_DEVIATION 6.7 | 63.44 years STANDARD_DEVIATION 10.29 |
| ASA Physical Status | 2.2 units on a scale STANDARD_DEVIATION 0.45 | 2.5 units on a scale STANDARD_DEVIATION 0.58 | 2.33 units on a scale STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 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 | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
| Weight | 80.58 kg STANDARD_DEVIATION 17.23 | 78.88 kg STANDARD_DEVIATION 22.49 | 79.82 kg STANDARD_DEVIATION 18.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Postoperative Opioid Consumption During First 72 Hours
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Time frame: 12 hours, 24 hours, 48 hours, 72 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Only | Postoperative Opioid Consumption During First 72 Hours | 12 hours | 11.69 MME | Standard Deviation 8.26 |
| Bupivacaine Only | Postoperative Opioid Consumption During First 72 Hours | 24 hours | 19.56 MME | Standard Deviation 13.14 |
| Bupivacaine Only | Postoperative Opioid Consumption During First 72 Hours | 48 hours | 30.66 MME | Standard Deviation 32.46 |
| Bupivacaine Only | Postoperative Opioid Consumption During First 72 Hours | 72 hours | 38.99 MME | Standard Deviation 39.03 |
| Liposomal Bupivacaine and Bupivacaine | Postoperative Opioid Consumption During First 72 Hours | 72 hours | 93.42 MME | Standard Deviation 31.35 |
| Liposomal Bupivacaine and Bupivacaine | Postoperative Opioid Consumption During First 72 Hours | 12 hours | 22.63 MME | Standard Deviation 4.02 |
| Liposomal Bupivacaine and Bupivacaine | Postoperative Opioid Consumption During First 72 Hours | 48 hours | 73.88 MME | Standard Deviation 15.05 |
| Liposomal Bupivacaine and Bupivacaine | Postoperative Opioid Consumption During First 72 Hours | 24 hours | 39.79 MME | Standard Deviation 19.36 |
Secondary
Change in Pain Score
Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.
Time frame: up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Only | Change in Pain Score | 6 hours post-operatively | 2.0 score on a scale | Standard Deviation 1.41 |
| Bupivacaine Only | Change in Pain Score | 48 hours post-operatively | 5.6 score on a scale | Standard Deviation 3.78 |
| Bupivacaine Only | Change in Pain Score | 1 hour post-operatively | 4.0 score on a scale | Standard Deviation 2.74 |
| Bupivacaine Only | Change in Pain Score | 72 hours post-operatively | 5.0 score on a scale | Standard Deviation 3.61 |
| Bupivacaine Only | Change in Pain Score | 12 hours post-operatively | 2.6 score on a scale | Standard Deviation 4.34 |
| Bupivacaine Only | Change in Pain Score | 6 weeks hours post-operatively | 2.4 score on a scale | Standard Deviation 3.36 |
| Bupivacaine Only | Change in Pain Score | 2 weeks hours post-operatively | 4.6 score on a scale | Standard Deviation 2.3 |
| Bupivacaine Only | Change in Pain Score | 12 weeks hours post-operatively | 2.2 score on a scale | Standard Deviation 3.19 |
| Bupivacaine Only | Change in Pain Score | 24 hours post-operatively | 2.8 score on a scale | Standard Deviation 2.77 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 12 weeks hours post-operatively | 3.0 score on a scale | Standard Deviation 1.41 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 6 hours post-operatively | 4.5 score on a scale | Standard Deviation 3.87 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 2 weeks hours post-operatively | 4.25 score on a scale | Standard Deviation 2.06 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 12 hours post-operatively | 3.75 score on a scale | Standard Deviation 3.3 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 24 hours post-operatively | 5.5 score on a scale | Standard Deviation 2.89 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 48 hours post-operatively | 5.0 score on a scale | Standard Deviation 3.56 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 72 hours post-operatively | 5.0 score on a scale | Standard Deviation 3.56 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 6 weeks hours post-operatively | 3.75 score on a scale | Standard Deviation 4.19 |
| Liposomal Bupivacaine and Bupivacaine | Change in Pain Score | 1 hour post-operatively | 4.5 score on a scale | Standard Deviation 3.11 |
Secondary
Hospital Length of Stay
Hospital length of stay (LOS)
Time frame: average 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Only | Hospital Length of Stay | 3 days | Standard Deviation 2.35 |
| Liposomal Bupivacaine and Bupivacaine | Hospital Length of Stay | 3.5 days | Standard Deviation 0.58 |
Secondary
Number of Participants With Postoperative Nausea/Vomiting (PONV)
Number of participants with postoperative nausea/vomiting (PONV) in PACU
Time frame: in PACU (4 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupivacaine Only | Number of Participants With Postoperative Nausea/Vomiting (PONV) | 0 Participants |
| Liposomal Bupivacaine and Bupivacaine | Number of Participants With Postoperative Nausea/Vomiting (PONV) | 0 Participants |
Secondary
Quality of Recovery (QOR 15)
Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Only | Quality of Recovery (QOR 15) | 123.2 score on a scale | Standard Deviation 7.39 |
| Liposomal Bupivacaine and Bupivacaine | Quality of Recovery (QOR 15) | 108.0 score on a scale | Standard Deviation 35.15 |
Secondary
Time to Ambulation
Time to ambulation in hours
Time frame: average 26-27 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Only | Time to Ambulation | 26.03 hours | Standard Deviation 12.58 |
| Liposomal Bupivacaine and Bupivacaine | Time to Ambulation | 27.13 hours | Standard Deviation 14.94 |