Clinical trial NCT04865211: Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide TLIP Block in Spinal Surgery
Official title: Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: thoracolumbar
spine
pain
postoperative
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in postoperative pain
timeFrame: 24-48 hours
measure: Total postoperative opioid requirements
timeFrame: 1-5 days
Secondary outcomes:
measure: Time to Ambulation
timeFrame: 1-5 days
measure: Length of Hospital Stay
timeFrame: 1-5 days
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References:
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.
citation: 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.
citation: 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.
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.