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

Cooper University Health Care

Status and phase: Unknown; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Injection; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04865211

Protocol #20-570

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Liposomal Bupivicaine

Experimental group

Description:

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

Treatment:

Drug: Liposomal bupivacaine

Bupivicane

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Injection

Placebo

Placebo Comparator group

Description:

Saline injection with 40mL preservative-free saline

Treatment:

Drug: Placebo