Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks

December 26, 2024 updated by: Hasnaa Gamal Khafagy, Kafrelsheikh University

Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks: A Prospective Randomized Study

The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section.

Study Overview

Detailed Description

Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.

Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.

Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.

Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.

Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).

Study Type

Interventional

Enrollment (Actual)

140

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

    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
        • Kafrelsheikh University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • American Society of Anesthesiologists (ASA) classification II.
  • Female patients scheduled for elective cesarean section under spinal anesthesia.

Exclusion Criteria:

  • Patient refusal.
  • Patients who are taking analgesics for chronic illness or have history of substance abuse.
  • Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
  • Patients with a history of coagulopathy.
  • Patients weight less than 60 kilograms.
  • Patient height less than 150 cm.
  • Patients with known local anesthetics and opioid allergy.
  • Patients with infection at the site of the needle puncture.
  • Patients with major respiratory, cardiac, renal, or hepatic disorders.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients will receive the standard spinal anesthesia with 0.5% hyperbaric bupivacaine (2.2ml)
Experimental: Erector spinae plane block group
Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.
Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.
Experimental: Posterior Quadratus lumborum plane block group
Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
Experimental: Lateral Transversus abdominis plane block group
Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.
Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morphine consumption
Time Frame: 24 hours postoperatively
The rescue analgesia will be morphine IV bolus 3 mg with 5-minute lock out interval when Numeric Rating Scale (NRS)>3, can be repeated till NRS˂3 guided with the occurrence of complication.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain
Time Frame: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at T1, 2, 4, 6, 12, 18, and 24 h postoperative.
24 hours postoperatively
Time for first request of the rescue analgesia
Time Frame: 24 hours postoperatively
Time for first request of the rescue analgesia will be assessed from the end of surgery to first dose of morphine administrated.
24 hours postoperatively
Complications
Time Frame: 24 hours postoperatively
Complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication will be recorded.
24 hours postoperatively
Degree of patient satisfaction
Time Frame: 24 hours postoperatively
Degree of patient satisfaction will be assessed using 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
24 hours postoperatively

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)

August 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 8, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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