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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2022-04-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Liposomal Bupivicaine

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

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

Use of liposomal bupivicaine as intraoperative local anesthesia

Bupivicane

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

Group Type ACTIVE_COMPARATOR

Bupivacaine Injection

Intervention Type DRUG

Use of bupivicaine as intraoperative local anesthesia

Placebo

Saline injection with 40mL preservative-free saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Use of saline as placebo for local anesthesia

Interventions

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Liposomal bupivacaine

Use of liposomal bupivicaine as intraoperative local anesthesia

Intervention Type DRUG

Bupivacaine Injection

Use of bupivicaine as intraoperative local anesthesia

Intervention Type DRUG

Placebo

Use of saline as placebo for local anesthesia

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes