Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion

Back Pain Clinical Trial

Official title:

Analgesic Requirement for Post-Operative Pain Control in Elective 1-3 Level Transforaminal Lumbar Interbody Fusion: Comparison of Thoracolumbar Interfascial Plane Block With Exparel to Bupivacaine HCl

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350981
• Other study ID #: FORE813
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Foundation for Orthopaedic Research and Education
• Contact: Sergio Aguilar
• Phone: 813-919-3687
• Email: saguilar[@]foreonline.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years or older,
• Patients admitted to AHC for 1-3 level TLIF,
• Patients who have given written informed consent,
• BMI between 18-35 kg/m2,

Exclusion Criteria:

• Patients with known allergic reactions to standard of care analgesics,
• Female patients who are pregnant
• Patients with any previous lumbar spine instrumented surgery,
• Chronic opioid use within 30 days prior to randomization that exceeds average =30 oral morphine equivalents/day,
• Patients with known allergy to local anesthetics,
• Patients with known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis).

Related Conditions & MeSH terms

• Back Pain
• Narcotic Use
• Pain, Postoperative
• Physical Stress
• Post Operative Pain

Intervention

Drug:
• Exparel
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
• Bupivacain
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL

Locations

Country	Name	City	State
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.	Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery.	0-72 hours post-operatively
Secondary	Total Postsurgical opioid consumption	The following data points will be recorded to further claim the investigators hypothesis of treatment with EXPAREL compared to Bupivacaine hydrochloride.; • Total postsurgical opioid consumption in oral morphine equivalents (Oral morphine equivalents) from 0 to 76 hours post-surgery	0-72 hours postoperatively
Secondary	Time to discharge	collect hours of hospital stay	0-72 hours postoperatively
Secondary	Time to ambulation	collect time ambulated from surgery	0-72 hours postoperatively
Secondary	Maximum ambulated distance	Physical Therapy will document the distance subject could ambulate after surgery	0-72 hours postoperatively
Secondary	Numeric Rating Pain Scale (Physical Therapy)	Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation)	0-72 hours postoperatively
Secondary	Numeric Rating Pain Scale	Numerical rating scale pain intensity scores at 24hour, 36hour, 60hour, and 72hour from the end of surgery and again at the first clinic visit postoperatively (scale of 0-10 with 0 indicates no pain and 10 severe pain)	0-72 hours with additional follow-up at 14 days (first clinic visit)
Secondary	Oswestry Disability Index (ODI)	10 questions relating to function specific to low back pain given before surgery and collected at 14 day post op visit.	0- 14 days postoperatively
Secondary	Pain Catastrophizing Scale (PCS)	This scale measures thoughts and feelings that may be associated with pain. it is rated 0-5 with 0 indicating not at all, 1 indicating to a slight degree, 2 indicates a moderate degree, 3 indicates a great degree and 4 idicates all the time.; There are 13 statements that are rated, the ratings are scored to determine where each subject falls in the scale.	0-14 days postoperatively