Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery

Phase 2

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine Injection; Drug: Placebo; Drug: Liposomal bupivacaine

• Registration Number: NCT04865211
• Lead Sponsor: The Cooper Health System

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

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-05
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29
• Primary Completion: 2022-02-17
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivicane	Bupivacaine Injection	Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000
Placebo	Placebo	Saline injection with 40mL preservative-free saline
Liposomal Bupivicaine	Liposomal bupivacaine	Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine

Primary Outcome Measures

Name	Time	Method
Total postoperative opioid requirements	1-5 days	Using daily MME
Reduction in postoperative pain	24-48 hours	Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	1-5 days	Number of postoperative days
Time to Ambulation	1-5 days	Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States