Clinical trial NCT04588389: Comparison of Quadratus Lumborum Block Types
Official title: Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Opioid Use
Lumbar Disc Herniation
Keywords: Lumbar Spine
Nerve Block
Opioid Use
Pain
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize 10 patients into one of three groups for a total of 30 patients. Each patient will be longitudinally followed until discharge.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Opioid Consumption
timeFrame: 12 hours
measure: Opioid Consumption
timeFrame: 24 hours
measure: Opioid Consumption
timeFrame: 36 hours
measure: Opioid Consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Pain Scale
timeFrame: 0 Hours
measure: Pain Scale
timeFrame: 1 Hours
measure: Pain Scale
timeFrame: 6 Hours
measure: Pain Scale
timeFrame: 12 Hours
measure: Pain Scale
timeFrame: 18 Hours
measure: Pain Scale
timeFrame: 24 Hours
measure: Pain Scale
timeFrame: 30 Hours
measure: Pain Scale
timeFrame: 36 Hours
measure: Pain Scale
timeFrame: 42 Hours
measure: Pain Scale
timeFrame: 48ours
measure: Discharge Opioid Use
timeFrame: 2 weeks
measure: Side Effects
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Eman Nada, MD
role: PRINCIPAL_INVESTIGATOR
References: