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

Overview

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 Title of Study: “Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 17, 2022

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

Interventions

  • Drug: Liposomal bupivacaine
    • Use of liposomal bupivicaine as intraoperative local anesthesia
  • Drug: Bupivacaine Injection
    • Use of bupivicaine as intraoperative local anesthesia
  • Drug: Placebo
    • Use of saline as placebo for local anesthesia

Arms, Groups and Cohorts

  • Experimental: Liposomal Bupivicaine
    • Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine
  • Active Comparator: Bupivicane
    • Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000
  • Placebo Comparator: Placebo
    • Saline injection with 40mL preservative-free saline

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Cooper Health System
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Christopher Bilbao, DO, 856-968-7965, bilbao-christopher@cooperhealth.edu

References

Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.

Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.

Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

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