Quadratus Lumborum Block After Living Donor Kidney Transplantation

December 23, 2022 updated by: Sun-Kyung Park, Seoul National University Hospital

Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

88

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

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital

Exclusion Criteria:

  • Patients with severe pain before surgery

    • Patients with a history hypersensitivity reactions on fentanyl or ropivacaine

      • Patients who cannot maintain patient-controlled analgesia (PCA) by themselves

        ④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied

        ⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transmuscular quadratus lumborum block group
Patients assigned to the Transmuscular Quadratus Lumborum (TQL) block group receive the Transmuscular Quadratus Lumborum block in a lateral decubitus position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.
Procedure: Transmuscular quadratus lumborum block
Patients assigned to the TQL block group receive the TQL block in a supine position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.
Placebo Comparator: Control group
For patients assigned to the control group, 30cc of 0.9% normal saline is used for Transmuscular Quadratus Lumborum block.
Procedure: Placebo
For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption for 24 postoperative hours
Time Frame: 24 hours postoperatively
Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesics
Time Frame: within post-operative 24 hours
Time to first rescue analgesics
within post-operative 24 hours
Rescue analgesics administration
Time Frame: within post-operative 48 hours
Rescue analgesics administration count
within post-operative 48 hours
Analgesic consumption
Time Frame: at postoperative 6, 12, 48 hours
Analgesic consumption at postoperative 6, 12, 48 hours
at postoperative 6, 12, 48 hours
Resting pain numeric rating scale(NRS)
Time Frame: at postoperative 6, 12, 24, 48 hours
Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48 hours. Numeric rating scare is 11-point scale from 0 to 10, The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).
at postoperative 6, 12, 24, 48 hours
Numeric rating scale of pain during movement
Time Frame: at postoperative 6, 12, 24, 48 hours
Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48 hours Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).
at postoperative 6, 12, 24, 48 hours
Numeric rating scale at post anesthetic care unit (PACU)
Time Frame: 30 minutes after the end of operation
Numeric rating scale at post anesthetic care unit Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).
30 minutes after the end of operation
The incidence of post-operative nausea and vomiting
Time Frame: within post-operative 48 hours
The incidence of post-operative nausea and vomiting
within post-operative 48 hours
Patient satisfaction with pain control
Time Frame: At post-operative 48 hours
Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction.
At post-operative 48 hours
Pattern of injectate spread on ultrasonography
Time Frame: During procedure quadratus lumborum (QL) block
Pattern of injectate spread on ultrasonography
During procedure quadratus lumborum (QL) block
Sensory blockade
Time Frame: 30 minutes after the end of operation
After surgery, an alcohol swab is used to evaluate the loss of cold sensation. It is evaluated by dividing into nine regions bordering the rib margin on the side of the surgery, the horizontal line passing through the umbilicus and pubis, and the vertical line of the midclavicular line, anterior axillary line, and mid axillary line. If cold sensation is the same as the opposite part of the regions, marked as 2 points, if decreased marked as 1 point, and if not sensed at all, marked as 0 point.
30 minutes after the end of operation
Quality of Recovery Questionnaire (15-item Quality of Recovery)
Time Frame: At post-operative 48 hours
Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.
At post-operative 48 hours
The severity of post-operative nausea and vomiting
Time Frame: within post-operative 48 hours
The severity of post-operative nausea and vomiting, The severity of the nausea and vomitting is asked to patient and expressed as none, mild, or severe.
within post-operative 48 hours

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sun-Kyung Park, M.D.,Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 3, 2021

Primary Completion (Actual)

May 18, 2022

Study Completion (Actual)

May 28, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2104-083-1211

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

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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