Phase 4
Completed N=34
A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.
Lumbar Spine Degeneration
Source: ClinicalTrials.gov NCT04644796 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Postoperative Opioid Utilization — 4.82; 9.17 morphine milligram equivalents
◆ Published Evidence
Highly cited
1,284citations · ~92 / year
Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management.
Summary
The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.
Linked Publications (5)
-
Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management.
-
A novel liposomal bupivacaine formulation to produce ultralong-acting analgesia.
-
The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients.
-
Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics.
-
Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Opioid Utilization |
4.82; 9.17 | — |
| SECONDARY Post Operative Pain Scores |
4.80; 4.05 | — |
| SECONDARY Length of Stay |
42.69; 29.51 | — |
| SECONDARY Operative Data and Complications |
17; 17; 0; 0; 15; 16 | — |
Eligibility Criteria
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 2mg/dl)
- Renal dysfunction (eGFR < 60ml/min/1.73m2)
- Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation
- Unable to give informed consent
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04644796) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.