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

April 26, 2021 updated by: The Cooper Health System

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Bilbao, DO
        • Sub-Investigator:
          • Paul Audu, MD
        • Sub-Investigator:
          • Steven Yocom, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Bupivicaine
Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine
Drug: Liposomal bupivacaine
Use of liposomal bupivicaine as intraoperative local anesthesia
Active Comparator: Bupivicane
Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000
Drug: Bupivacaine Injection
Use of bupivicaine as intraoperative local anesthesia
Placebo Comparator: Placebo
Saline injection with 40mL preservative-free saline
Drug: Placebo
Use of saline as placebo for local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24-48 hours
Total postoperative opioid requirements
Time Frame: 1-5 days
Using daily MME
1-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Ambulation
Time Frame: 1-5 days
Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented
1-5 days
Length of Hospital Stay
Time Frame: 1-5 days
Number of postoperative days
1-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Anticipated)

February 17, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol #20-570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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