Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain

October 18, 2021 updated by: Christopher Ryalino, MD, Udayana University

Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain

Acute pain is reported in approximately 80% of patients undergoing postoperative care for various types of surgical procedures in the United States. Another study reported patient postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days and 38% reporting moderate to severe pain at 14 postoperative days. Several modalities have been used as the standard for the management of pain postoperative C-sections.

One of the postoperative analgesic modalities for SC is quadratus lumborum block (QLB). This technique has advantages in relieving postoperative pain after C-section because it is considered to be able to relieve visceral pain as well as somatic pain. The transmuscular QLB (QLBT) approach is one of the most frequently used. This technique was found to be effective with regard to the distribution of analgesics to the paravertebral spaces which is the hallmark of QLB. However, this technique was found to be difficult to perform. Difficulties were reported related to the position of the procedure i.e. lateral or sitting position.

Study Overview

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

    • Bali
      • Denpasar, Bali, Indonesia, 80114
        • Sanglah General Hospital

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 to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Underwent C-section with subarachnoid block
  • Aged 18-35 years old.
  • ASA preoperative physical status 1-2

Exclusion Criteria:

  • Coagulopathy
  • Anatomic abnormalities of the abdomen
  • History of allergy to local anesthesia
  • History of hyperalgesia
  • History of drug abuse (sedatives, opioids, paracetamol, or other pain relievers)
  • Require postoperative intensive care
  • Refuse to participate in research.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quadratus lumborum intramuscular block
The quadratus lumborum intramuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists.
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
Active Comparator: Quadratus lumborum transmucular block
The quadratus lumborum transmuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists.
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Up to 24 hours after surgery
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Up to 24 hours after surgery
Postoperative morphine requirements
Time Frame: Up to 72 hours after surgery
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
Up to 72 hours after surgery

Collaborators and Investigators

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

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)

September 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UNUD-CTR-FK150621-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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