Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

May 22, 2016 updated by: Corniche Hospital

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.

The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.

Study Overview

Detailed Description

After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.

All the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.

All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.

Study Type

Interventional

Enrollment (Actual)

76

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Elective caesarean sections ASA 1 to 3 Written informed consent.

Exclusion Criteria:

Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quadratus Lumborum block group

Quadratus Lumborum block group (QL)

patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
Other Names:
  • QLB
Active Comparator: Transversus abdominis plane block group

Transversus abdominis plane block (TAP)

patients will receive a bilateral TAP block using Bupivicaine 0.125%

0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
Other Names:
  • TAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine used in the first 48 hours after surgery
Time Frame: 48 hours
Total cumulative morphine dose in mg used in the first 48 hours after surgery
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of postoperative pain via visual analogue pain scale (VAS)
Time Frame: 48 hours
VAS range from 0 for no pain to 10 for worst pain imaginable
48 hours
Nausea or vomiting
Time Frame: 48 hours

0 = No Nausea

  1. = Mild Nausea.
  2. = Moderate
  3. = Severe Nausea or Vomiting
48 hours
Sedation score
Time Frame: 48 hours
  1. = drowsy but responds to normal verbal communication.
  2. = asleep, but awakes with verbal communication.
  3. = asleep, awakens with mild physical stimulation.
  4. = asleep, unresponsive to mild physical stimulation.
48 hours

Collaborators and Investigators

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

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.

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

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Ch23031404

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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