A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block for Post-cesarean Delivery Analgesia

September 18, 2024 updated by: Vishal Uppal, Nova Scotia Health Authority

A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block As Part of a Multimodal Analgesia Strategy for Post-cesarean Delivery Analgesia

Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her baby and may contribute to developing long term pain and disability. Women having a CD receive pain medication (morphine) as part of their spinal anesthetic to help with pain relief after surgery. Morphine works well however has several side effects such as nausea, vomiting and itching which may be severe enough to make it difficult to care for herself and her new baby. In some cases, morphine causes difficulty in passing urine within first 24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to provide effective pain control without the side-effects associated with the spinal morphine. This study is to determine if women receiving QLB have as good pain control with fewer side effects than those who do receive the spinal morphine. Adequate pain control will be assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of the two techniques, quality of recovery and long term impact will also be compared during this study.

In addition, we would like to compare the patients who received both analgesic regimens (ITM and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB). Further, the study will help us answer if combining the two analgesic interventions if beneficial or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Canada
      • Halifax, Canada
        • IWK Health Centre

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

No

Description

Inclusion Criteria:

  • Non-emergent CD with planned spinal anesthesia
  • American Society of Anesthesia physical status class I & II;
  • Age ≥18 years;
  • Term gestational age (≥37 weeks);
  • Singleton pregnancy;
  • English-speaking.

Exclusion Criteria:

  • Morbid Obesity (BMI ≥35 kg/m2);
  • Subjects with significant obstetric or neonatal co-morbidities;
  • Patient enrollment in another study involving medication within 30 days of CD;
  • Any other condition, which may impair patients ability to co-operate with data collection;
  • Patient height less than 152 cm (5'0");
  • History of opioid tolerance or sensitivity;
  • Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs);
  • Women with a history of illicit drug use or prescribed opioids or benzodiazepines.

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
Active Comparator: Intrathecal morphine
Intrathecal morphine 100 mcg
Other: Intrathecal Morphine with 100 mcg morphine
Intrathecal Morphine with 100 mcg morphine
Experimental: Quadratus lumborum block
Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg)
Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine
Bilateral Quadratus lumborum block with 0.5% ropivacaine
Experimental: Intrathecal morphine + Quadratus lumborum block
Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg
Other: Intrathecal Morphine with 100 mcg morphine
Intrathecal Morphine with 100 mcg morphine
Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine
Bilateral Quadratus lumborum block with 0.5% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of recovery (QoR) score
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine equivalent consumption
Time Frame: 24 hours and 48 hours
morphine equivalent consumption in the 24-h and 48-h period after spinal insertion
24 hours and 48 hours
Quality of recovery (QoR) score
Time Frame: 48 hours
48 hours
Incidence of nausea/vomiting needing treatment
Time Frame: 24 hours
24 hours
Incidence of itching needing treatment.
Time Frame: 24 hours
24 hours
Incidence of respiratory depression needing treatment.
Time Frame: 24 hours
24 hours
Worst pain scores
Time Frame: 24 hours
The primary outcome will be highest pain intensity during first 24-h as measured
24 hours

Collaborators and Investigators

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

Sponsor

Nova Scotia Health Authority

Collaborators

Maisonneuve-Rosemont Hospital
IWK Health Centre

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)

May 30, 2017

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

April 27, 2024

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimated)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1021219

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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