A Randomized Controlled Trial of the Effect of Liposomal Bupivacaine (Exparel) When Compared to Saline Control in Reducing Opioid Utilization for Pain Management in Postoperative Lumbar Spine Surgeries.

2037544

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

2021-02-10

2022-06-13

2022-06-13

Completed

Early phase I

34

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2023-06-13