Lumbar Spine Degeneration
Conditions
Brief summary
The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.
Detailed description
Multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. Many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. Liposomal bupivacaine (LB) (Exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. LB has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. The goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital stay.
Interventions
DRUGsaline 0.9%
Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
DRUGLiposomal bupivacaine
Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Liposomal bupivacaine can be differentiated visually from normal saline. In order to blind the surgeons from treatment vs control, the syringes containing the medication or saline will be sheathed by the investigational drug study department.
Intervention model description
Patients will be randomly assigned to either the treatment group or the placebo group. Patients in the study group will receive liposomal bupivacaine at the end of the procedure (following fascial closure, but prior to superficial closure), while patients in the placebo group will receive sterile saline. The injectate should be injected slowly and deeply, infusing \ 1-2 mL according to manufacture guidelines for infiltration. According to these guidelines, injection should utilize a moving needle technique (inject while withdrawing the needle) at multiple locations surrounding the incision(s) to achieve maximal effect. Care will be taken to aspirate prior to injection to minimize the risk of intravascular injection of medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing isolated lumbar spine procedures using a posterior approach. * Surgical spine procedures include: * Single-level lumbar spine surgeries with or without fusion * Multi-level lumbar spine surgeries with or without fusion
Exclusion criteria
* Procedures involving intrathecal space * Patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine). * Acute lumbar trauma that requires immediate spine stabilization * Revision of failed back surgeries (including nonunion and malunion) * Revision of wound or hardware * Contraindication to regional anesthesia * Patients with chronic use of opioid medications * Liver dysfunction (INR \> 1.5, albumin \<2.8g/dl, bilirubin \>2mg/dl) * Renal dysfunction (eGFR \< 60ml/min/1.73m2) * Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation * Unable to give informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Utilization | Until final follow-up, up to 8 weeks. | Comparing post operative opioid usage reduction between treatment and placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Scores | Until final follow-up or up to 8 weeks after surgery date, whichever comes first. | Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life. |
| Length of Stay | Until final follow-up, up to 8 weeks. | Determining how long patient is in hospital. |
| Operative Data and Complications | Until final follow-up, up to 8 weeks. | Comparing intraoperative complications, acute postoperative complication, and opioid complications. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery. | 17 |
| Placebo Group Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Liposomal Bupivacaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 16 Participants | 8 Participants |
| Age, Continuous | 65 years | 64 years | 63 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 17 participants | 34 participants | 17 participants |
| Sex: Female, Male Female | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Postoperative Opioid Utilization
Comparing post operative opioid usage reduction between treatment and placebo group.
Time frame: Until final follow-up, up to 8 weeks.
Population: Discrepancy comes from patients not reporting morphine milligram equivalents on survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Postoperative Opioid Utilization | 4.82 morphine milligram equivalents | Standard Deviation 10.02 |
| Liposomal Bupivacaine | Postoperative Opioid Utilization | 9.17 morphine milligram equivalents | Standard Deviation 19.36 |
Secondary
Length of Stay
Determining how long patient is in hospital.
Time frame: Until final follow-up, up to 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Length of Stay | 42.69 Hours | Standard Deviation 40.62 |
| Liposomal Bupivacaine | Length of Stay | 29.51 Hours | Standard Deviation 19.32 |
Secondary
Operative Data and Complications
Comparing intraoperative complications, acute postoperative complication, and opioid complications.
Time frame: Until final follow-up, up to 8 weeks.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Group | Operative Data and Complications | Intraoperative Complications | None | 17 Participants |
| Placebo Group | Operative Data and Complications | Acute Postoperative Complication | Yes | 2 Participants |
| Placebo Group | Operative Data and Complications | Opioid Complications | None | 17 Participants |
| Placebo Group | Operative Data and Complications | Intraoperative Complications | Yes | 0 Participants |
| Placebo Group | Operative Data and Complications | Opioid Complications | Yes | 0 Participants |
| Placebo Group | Operative Data and Complications | Acute Postoperative Complication | None | 15 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Opioid Complications | Yes | 0 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Intraoperative Complications | None | 17 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Acute Postoperative Complication | None | 16 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Acute Postoperative Complication | Yes | 1 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Opioid Complications | None | 17 Participants |
| Liposomal Bupivacaine | Operative Data and Complications | Intraoperative Complications | Yes | 0 Participants |
Secondary
Post Operative Pain Scores
Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.
Time frame: Until final follow-up or up to 8 weeks after surgery date, whichever comes first.
Population: Reason for participant discrepancy is patients did not fill our VAS pain score survey following surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Post Operative Pain Scores | 4.80 score on a scale | Standard Deviation 1.92 |
| Liposomal Bupivacaine | Post Operative Pain Scores | 4.05 score on a scale | Standard Deviation 1.74 |