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Clinical Trials/NCT04865211
NCT04865211
Unknown
Phase 2

Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery

The Cooper Health System1 site in 1 country90 target enrollmentApril 5, 2021

Overview

Phase
Phase 2
Intervention
Liposomal bupivacaine
Conditions
Pain, Postoperative
Sponsor
The Cooper Health System
Enrollment
90
Locations
1
Primary Endpoint
Reduction in postoperative pain
Last Updated
5 years ago

Overview

Brief Summary

The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery

Detailed Description

Patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. Spine surgeons are looking for ways to reduce the pain that you experience. Anesthesiologists have introduced a procedure, called a "TLIP block" to provide pain relief. The block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. This block has been used by other surgeons for other types of surgeries in the past and has been shown to work. To determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared

Registry
clinicaltrials.gov
Start Date
April 5, 2021
End Date
April 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients undergoing multilevel lumbar spine surgery, age 18-75

Exclusion Criteria

  • Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy

Arms & Interventions

Liposomal Bupivicaine

Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine

Intervention: Liposomal bupivacaine

Bupivicane

Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000

Intervention: Bupivacaine Injection

Placebo

Saline injection with 40mL preservative-free saline

Intervention: Placebo

Outcomes

Primary Outcomes

Reduction in postoperative pain

Time Frame: 24-48 hours

Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain

Total postoperative opioid requirements

Time Frame: 1-5 days

Using daily MME

Secondary Outcomes

  • Length of Hospital Stay(1-5 days)
  • Time to Ambulation(1-5 days)

Study Sites (1)

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