Comparison of Quadratus Lumborum Block Types
- Conditions
- Opioid UsePainLumbar Disc Herniation
- Interventions
- Drug: Multimodal Pharmacological Management
- Registration Number
- NCT04588389
- Lead Sponsor
- Eman Nada
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Adult Patients undergoing lumbar spinal fusion surgery.
- Patients from 40-80 years.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Standard of Care + Quadratus Lumborum Block III Ropivacaine injection Location 2 Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient. Group 2 Standard of Care + Quadratus Lumborum Block III Multimodal Pharmacological Management Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient. Group 1 Standard of Care Multimodal Pharmacological Management Group I will receive the standard of care multimodal pharmacological management. Group 2 Standard of Care + Quadratus Lumborum Block II Ropivacaine injection Location 1 Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group 2 Standard of Care + Quadratus Lumborum Block II Multimodal Pharmacological Management Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
- Primary Outcome Measures
Name Time Method Opioid Consumption 48 hours Dose of the opioids consumed
- Secondary Outcome Measures
Name Time Method Discharge Opioid Use 2 weeks The amount of left-over opioid pills at 2 weeks in the follow up visit.
Pain Scale 48ours Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Side Effects Up to 1 week The presence of any side effects reported.
Trial Locations
- Locations (1)
UMASS Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States