Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy

June 18, 2017 updated by: Amiruddin Nik Mohamed Kamil, Kuala Lumpur General Hospital

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Total Abdominal Hysterectomy

Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia.

Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies.

The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA I or II
  2. Patient's weight > 50kg
  3. Elective TAH

Exclusion Criteria:

  1. Body mass index (BMI) > 35 kg/m2
  2. Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA
  3. Inability to use patient controlled analgesia
  4. Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition

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
Experimental: Transmuscular quadratus lumborum (QL) block
Bilateral QL block using 20 ml 0.375% ropivacaine in each side (to a maximum dose 3 mg/kg) plus patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative
Drug: ropivacaine
Drug: morphine
Procedure: Transmuscular quadratus lumborum block
Active Comparator: Control
Patient controlled analgesia morphine (1mg/bolus morphine, lockout time 5 minutes) post operative
Drug: morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative morphine consumption
Time Frame: 24 hours after total abdominal hysterectomy
in mg for 24 hours
24 hours after total abdominal hysterectomy
Pain score at rest and movement
Time Frame: 24 hours after total abdominal hysterectomy
using visual analogue scale 1 to 10
24 hours after total abdominal hysterectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications related to the transmuscular QL block
Time Frame: 24 hours after total abdominal hysterectomy
Complications related to transmuscular QL block: Haematoma at site of injection,infection at site of injection Complications related to PCAM:Nausea, vomiting, pruritus, sedation
24 hours after total abdominal hysterectomy

Collaborators and Investigators

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

Sponsor

Kuala Lumpur General Hospital

Investigators

  • Principal Investigator: Amiruddin Nik Mohamed Kamil, MBBS MMed (Anaesthesiology), Kuala Lumpur General 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

Helpful Links

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

November 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 18, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-15-919-25992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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