Comparison of Quadratus Lumborum Block Types

Pain Clinical Trial

Official title:

Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588389
• Other study ID #: H00016236
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: University of Massachusetts, Worcester
• Contact: Ryan M DeWolf, MS
• Phone: 9783021857
• Email: ryan.dewolf[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption.

Description:

This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult Patients undergoing lumbar spinal fusion surgery.

• Patients from 40-80 years.

Exclusion Criteria:

• Recent drug abuse

• History of illicit drug use

• Chronic pain patients not related to the back lesions.

• Opioid tolerant patients.

• Patients with any lower extremity weaknesses or deficits.

• Patients with American Society of Anesthesiologists (ASA) classification more than 3.

• Coagulopathy.

• Infection near or in the area of the block.

• Pregnant patients.

• Uncooperative patients who refuse care which directly effects research participation or clinical care.

• If the surgeon reports performing non-typical fusion.

• The presence of intraoperative complications like nerve injury or abnormal results of neuromonitoring and extensive dissection.

• Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.)

• Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control)

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation
• Opioid Use
• Pain

Intervention

Drug:
• Ropivacaine injection Location 1
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
• Ropivacaine injection Location 2
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
• Multimodal Pharmacological Management
standard of care multimodal pharmacological management

Locations

Country	Name	City	State
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eman Nada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Dose of the opioids consumed	12 hours
Primary	Opioid Consumption	Dose of the opioids consumed	24 hours
Primary	Opioid Consumption	Dose of the opioids consumed	36 hours
Primary	Opioid Consumption	Dose of the opioids consumed	48 hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	0 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	1 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	6 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	12 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	18 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	24 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	30 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	36 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	42 Hours
Secondary	Pain Scale	Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.	48ours
Secondary	Discharge Opioid Use	The amount of left-over opioid pills at 2 weeks in the follow up visit.	2 weeks
Secondary	Side Effects	The presence of any side effects reported.	Up to 1 week