Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy

June 24, 2020 updated by: Eric Bolin, Medical University of South Carolina
To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing laparoscopic assisted donor nephrectomy
  • Patients that have elected to have a nerve block
  • 18 years of age or older
  • Patients of ASA status I - III

Exclusion Criteria:

  • Chronic pain or narcotic usage during the preceding 30 days
  • Infection at or near the intended needle insertion site
  • Complex or altered abdominal wall anatomy
  • Weight <45kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QL Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
Procedure: QL Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
Active Comparator: TAP Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
Procedure: TAP Block
Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Pain Score
Time Frame: 24 hours post operative
NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative.
24 hours post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cumulative Opioids
Time Frame: 72 hours
opiate consumption first 72 hours post operatively
72 hours
Number of Participants With Nausea or Emesis Requiring Antiemetic Medication
Time Frame: 24 hours
Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU.
24 hours
Number of Participants With Block Related Complications
Time Frame: 24 hours
24 hours
Length of Stay in Post Anesthesia Care Unit (PACU)
Time Frame: 24 hours
Duration of PACU stay.
24 hours
Length of Hospital Stay
Time Frame: 3 days
The time from surgery completion to subject meeting discharge criterion.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

May 22, 2019

Study Completion (Actual)

May 22, 2019

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00073925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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