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Comparison of Quadratus Lumborum Block Types

Primary Purpose

Pain, Opioid Use, Lumbar Disc Herniation

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine injection Location 1
Ropivacaine injection Location 2
Multimodal Pharmacological Management
Sponsored by
Eman Nada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Lumbar Spine, Nerve Block, Opioid Use, Pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UMASS Memorial Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group 1 Standard of Care

Group 2 Standard of Care + Quadratus Lumborum Block II

Group 2 Standard of Care + Quadratus Lumborum Block III

Arm Description

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. We will measure opioid use, pain, and side effects in each patient.

Outcomes

Primary Outcome Measures

Opioid Consumption
Dose of the opioids consumed
Opioid Consumption
Dose of the opioids consumed
Opioid Consumption
Dose of the opioids consumed
Opioid Consumption
Dose of the opioids consumed

Secondary Outcome Measures

Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Pain Scale
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Discharge Opioid Use
The amount of left-over opioid pills at 2 weeks in the follow up visit.
Side Effects
The presence of any side effects reported.

Full Information

First Posted
September 30, 2020
Last Updated
March 18, 2021
Sponsor
Eman Nada
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1. Study Identification

Unique Protocol Identification Number
NCT04588389
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eman Nada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Opioid Use, Lumbar Disc Herniation
Keywords
Lumbar Spine, Nerve Block, Opioid Use, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
For the blinding purposes, the patients will be told that there are two possible sites at which they will receive the block. The sites will be either in the operating room before you wake up from anesthesia or in the post-anesthesia care unit (PACU). The patients on the medical management group will be told that they have received their block before recovering from anesthesia, the PACU nurse will be told the same as well to make him or her blinded as a pain assessor.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Standard of Care
Arm Type
Active Comparator
Arm Description
Group I will receive the standard of care multimodal pharmacological management.
Arm Title
Group 2 Standard of Care + Quadratus Lumborum Block II
Arm Type
Experimental
Arm Description
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
Arm Title
Group 2 Standard of Care + Quadratus Lumborum Block III
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection Location 1
Other Intervention Name(s)
Lidocaine
Intervention Description
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection Location 2
Other Intervention Name(s)
Lidocaine
Intervention Description
Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
Intervention Type
Drug
Intervention Name(s)
Multimodal Pharmacological Management
Intervention Description
standard of care multimodal pharmacological management
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Dose of the opioids consumed
Time Frame
12 hours
Title
Opioid Consumption
Description
Dose of the opioids consumed
Time Frame
24 hours
Title
Opioid Consumption
Description
Dose of the opioids consumed
Time Frame
36 hours
Title
Opioid Consumption
Description
Dose of the opioids consumed
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
0 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
1 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
6 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
12 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
18 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
24 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
30 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
36 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
42 Hours
Title
Pain Scale
Description
Numerical Pain Scale Rating, likert scale of 0-10 with a 0 indicating absence of pain and 10 indicating worst pain imaginable.
Time Frame
48ours
Title
Discharge Opioid Use
Description
The amount of left-over opioid pills at 2 weeks in the follow up visit.
Time Frame
2 weeks
Title
Side Effects
Description
The presence of any side effects reported.
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan M DeWolf, MS
Phone
9783021857
Email
ryan.dewolf@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan M DeWolf, ms
Phone
7743032649
Email
ryan.dewolf@umassmemorial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Nada, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers. However, results of the study will be shared through publication.

Learn more about this trial

Comparison of Quadratus Lumborum Block Types

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