A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2022-06-13

Brief Summary

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The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.

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Detailed Description

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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.

Conditions

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Lumbar Spine Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Placebo Group

Patients in this group will be given the placebo (sterile saline).

Group Type PLACEBO_COMPARATOR

saline 0.9%

Intervention Type DRUG

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.

Liposomal bupivacaine

Patients in this group will be given the study drug (liposomal bupivacaine).

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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sterile saline Exparel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No