Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section

September 24, 2019 updated by: Mahidol University

Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have additional compelling reasons to provide adequate pain relief as early mobilization is a key factor to prevent the risk of thromboembolic event which is increased during pregnancy. Beside these, patients need to be pain free to takecare for their newborn and breastfeed them. Poorly controlled pain after cesarean section also increases risk of chronic pain and postpartum depression.

Intrathecal morphine is considered the "gold standard" for postoperative pain relief after cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its widespread use is due to its favorable pharmacokinetic profile, ease of administration and low cost. Although intrathecal morphine is highly effective, its use is associated with undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall patients' satisfaction. More serious complication is the risk of delayed maternal respiratory depression.

The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long lasting block with the potential to provide visceral pain relief. Therefore, this block has an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety is concerned, there has been one report of a patient with unilateral hip flexion and knee extension weakness leading to unplanned overnight admission following lateral quadratus lumborum block after laparoscopic gynaecological operation.

If the result favors effective, it will have the advantage of a combination with intrathecal opioid to prolong the pain free period after cesarean section which has about 4,000 cases per year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All singleton pregnant women with gestation of at least 37 weeks scheduled for elective cesarean section with American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion Criteria:

  1. refuse to receive spinal block
  2. allergy to drugs used in research: morphine, local anesthetic drug and paracetamol
  3. abnormal coagulopathy: congenital coagulopathy or who used anticoagulants
  4. platelet dysfunction or thrombocytopenia
  5. distorted anatomical structures of lumbar spines
  6. systemic infection or local infection at both flank areas which are the punctures sites for quadratus lumborum block
  7. unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Intrathecal morphine
Intrathecal morphine 0.2 mg, 0.9%NSS each side
Drug: Intrathecal morphine
0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia
Experimental: Intrathecal morphine with bilateral Quadratus Lumborum Block
Intrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side
Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block
0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia and 0.25% Bupivacaine 25 ml each side for quadratus lumborum block
Experimental: Bilateral Quadratus Lumborum Block
No intrathecal morphine, 0.25%Bupivacaine 25 ml each side
Drug: Bilateral Quadratus Lumborum Block
0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic request (PCA morphine)
Time Frame: 48 hours postoperatively
Whether bilateral quadratus lumborum block can increase pain free period of patients undergo cesarean section under spinal block with intrathecal morphine or not
48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 48 hours postoperatively
Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
48 hours postoperatively
Requirement of rescue pain
Time Frame: 48 hours postoperatively
Requirement of pain control medication
48 hours postoperatively
Adverse effect
Time Frame: 48 hours postoperatively
Incidence of side effects e.g. nausea and vomiting, itching and sedation
48 hours postoperatively
Satisfaction score
Time Frame: 48 hours postoperatively
Satisfaction score rated from 0-100
48 hours postoperatively

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Pawinee Pangthipampai, M.D., Siriraj 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)

September 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817/2559(EC1)

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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