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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865211
• Other study ID #: Protocol #20-570
• Status: Recruiting
• Phase: Phase 2
• Start date: April 5, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2021
• Source: The Cooper Health System
• Contact: Christopher Bilbao, DO
• Phone: 856-968-7965
• Email: bilbao-christopher[@]cooperhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Ueshima H, Hara E, Otake H. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in postoperative pain	Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain	24-48 hours
Primary	Total postoperative opioid requirements	Using daily MME	1-5 days
Secondary	Time to Ambulation	Daily physical therapy evaluations where ambulation is recorded and time from surgery is documented	1-5 days
Secondary	Length of Hospital Stay	Number of postoperative days	1-5 days