search
Back to results

Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies

Primary Purpose

Analgesia, Postoperative Pain, Block

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Sponsored by
Bruce Ben-David
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients 18-90 years old
  2. Patients undergoing nephrectomy
  3. Body Mass Index 19-36
  4. Male and Female
  5. All races
  6. American Society of Anesthesiologist scale I, II, III

Exclusion Criteria:

  1. Patient refusal
  2. Pregnancy
  3. Non-English speaking or inability to participate in the study
  4. Patients with coagulopathy or With International Normalized Ratio >1,5 the day of the surgery.
  5. Chronic steroid use
  6. Chronic pain
  7. Chronic opiate use

Sites / Locations

  • UPMC shadyside hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

low volume High concentration group

high volume low concentration

Arm Description

1.Low Volume: 30 subjects randomized to Low Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,75% ropivacaine x 15 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg

2.High Volume: 30 subjects randomized to High Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,375% ropivacaine x 30 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg

Outcomes

Primary Outcome Measures

pain control over the next 72 hours after surgery: Visual analogue scale
Visual analogue scale (0-10) measurement

Secondary Outcome Measures

opioid consumption during the first 72 hours
opioid consumption in morphine milliequivalents during the first 72 hours
time of the first opioid consumption after surgery
time after surgery that patient takes to require opioid medication after surgery
100 feet walking
time after surgery that the patient takes in order to be able to walk 100 feet
presence or absence of muscular weakness after Quadratus lumborum type 2 block
muscular weakness is associated sometime with femoral quadratus muscle weakness

Full Information

First Posted
August 30, 2019
Last Updated
February 12, 2021
Sponsor
Bruce Ben-David
search

1. Study Identification

Unique Protocol Identification Number
NCT04077398
Brief Title
Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies
Official Title
Volume Versus Concentration: a Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Bilateral Quadratus Lumborum Blocks Using High Volume/Low Concentration or Low Volume/ High Concentration Local Anesthetic in Nephrectomies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
covid interrupted initial start, then trainees involved finished program and no one took it on
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruce Ben-David

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The quadratus lumborum has since 2016 become standard of care for abdominal and retroperitoneal surgeries at UPMC-Shadyside Hospital, replacing paravertebral blocks, and as part of a broader multimodal analgesia institutional Enhanced Recovery After surgery protocol. Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. What is proposed here is to investigate the relative clinical effectiveness of the relationship high volume/low concentration of local anesthetic or low volume/ high concentration of local anesthetic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Postoperative Pain, Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization will be performed with software excel or spss. This randomization will be kept in an envelope. After the patient consents participation in the study, the investigator and the care provider will open the envelope and will perform the block according to the established in the randomization. The patient or the outcomes assessor will not have access to the volume and concentration used during the block. Will be the responsibility of investigators to keep in a safe place the information about the block received by the patients.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low volume High concentration group
Arm Type
Experimental
Arm Description
1.Low Volume: 30 subjects randomized to Low Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,75% ropivacaine x 15 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg
Arm Title
high volume low concentration
Arm Type
Experimental
Arm Description
2.High Volume: 30 subjects randomized to High Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,375% ropivacaine x 30 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
There will be two groups, in order to compare two different sets of volumes with the same amount of drug. we will try to identify if it is better one volume over the other in terms of pain control and consume of opioids, as well the presence or absence of motor weakness.
Primary Outcome Measure Information:
Title
pain control over the next 72 hours after surgery: Visual analogue scale
Description
Visual analogue scale (0-10) measurement
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
opioid consumption during the first 72 hours
Description
opioid consumption in morphine milliequivalents during the first 72 hours
Time Frame
72 hours
Title
time of the first opioid consumption after surgery
Description
time after surgery that patient takes to require opioid medication after surgery
Time Frame
24 hours
Title
100 feet walking
Description
time after surgery that the patient takes in order to be able to walk 100 feet
Time Frame
48 hours
Title
presence or absence of muscular weakness after Quadratus lumborum type 2 block
Description
muscular weakness is associated sometime with femoral quadratus muscle weakness
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18-90 years old Patients undergoing nephrectomy Body Mass Index 19-36 Male and Female All races American Society of Anesthesiologist scale I, II, III Exclusion Criteria: Patient refusal Pregnancy Non-English speaking or inability to participate in the study Patients with coagulopathy or With International Normalized Ratio >1,5 the day of the surgery. Chronic steroid use Chronic pain Chronic opiate use
Facility Information:
Facility Name
UPMC shadyside hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to share individual participant data.
Citations:
PubMed Identifier
26735154
Citation
Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
Results Reference
background

Learn more about this trial

Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies

We'll reach out to this number within 24 hrs