Comparison of Quadratus Lumborum Block Types

Study Overview
=================
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.

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

Conditions
-----------------
Opioid Use, Lumbar Disc Herniation, Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine injection Location 1
* Drug: Ropivacaine injection Location 2
* Drug: Multimodal Pharmacological Management


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Standard of Care<br>Group I will receive the standard of care multimodal pharmacological management. | Drug: Multimodal Pharmacological Management<br>* standard of care multimodal pharmacological management<br>|
| Experimental: Group 2 Standard of Care + Quadratus Lumborum Block II<br>Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. | Drug: Ropivacaine injection Location 1<br>* Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1<br>* Other names: Lidocaine;Drug: Multimodal Pharmacological Management<br>* standard of care multimodal pharmacological management<br>|
| Experimental: Group 2 Standard of Care + Quadratus Lumborum Block III<br>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. | Drug: Ropivacaine injection Location 2<br>* Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2<br>* Other names: Lidocaine;Drug: Multimodal Pharmacological Management<br>* standard of care multimodal pharmacological management<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Dose of the opioids consumed | 12 hours | 
| Opioid Consumption | Dose of the opioids consumed | 24 hours | 
| Opioid Consumption | Dose of the opioids consumed | 36 hours | 
| Opioid Consumption | Dose of the opioids consumed | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Discharge Opioid Use | The amount of left-over opioid pills at 2 weeks in the follow up visit. | 2 weeks | 
| Side Effects | The presence of any side effects reported. | Up to 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Spine, Nerve Block, Opioid Use, Pain