Ultrasound-Guided TAP Block and Spinal Morphine for Pain Relief After Caesarean Section

April 9, 2022 updated by: Islam Mokhtar Ahmed, Sohag University

Comparative Study Between Ultrasound-Guided Transversus Abdominis Plane Block and Spinal Morphine for Pain Relief After Elective Caesarean Section

This interventional double-blind randomized controlled study was carried out on 60 cases underwent elective caesarean section delivery, they were divided into 2 groups; patients were randomly allocated into two equal groups; Group M: received intrathecal 150 microgram morphine in a 0.5 ml volume, mixed with 10 mg of hyperbaric bupivacaine 0.5 % in a 2 ml volume (total volume 2.5 ml). Group B: received intrathecal 10 mg hyperbaric bupivacaine 0.5% 2ml volume + 0.5 saline (Total volume 3ml) and at the end of surgery patient received bilateral TAP block with 20 ml volume of 0.25% bupivacaine on each side.

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

  • Egypt
      • Sohag, Egypt
        • Faculty of Medicine, Sohag 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant females scheduled for elective cesarean section

Exclusion Criteria:

  • Patient refusal Patients with known allergies or with past history of allergy to local anesthesia Patients having an infection at the site of injection either in the back or in the abdominal region, Patients with coagulopathy or on systemic anticoagulation, Chronic opioid abuse, significant neurological, psychiatric or neuromuscular disease, Drug abuse and alcoholism, Obesity (BMI 30 and higher), Cardiovascular disease and Endocrine 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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transversus abdominis plain block group
post-cesarean section tap block will be given by ultrasound guidance using 20 ml bupivacaine local anesthetic 0.25% concentration for each side as an adjuvant to spinal anesthesia
Procedure: Ultrasound-Guided Transversus Abdominis Plane Block
patient in the supine position, ultrasound will be used to identify the plane between the internal oblique and transversus abdominis muscle to inject 20 ml of local anesthetic for each side
Experimental: intrathecal morphia group
intrathecal 150 microgram morphine in a 0.5 ml volume as an adjuvant to spinal anesthesia
Drug: Morphine
intrathecal 150 microgram morphine in a 0.5 ml volume will be added to bupivacaine as an adjuvant to spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of post-operative pain
Time Frame: 72 hours
reduction of visual analogue scale post-operative
72 hours

Collaborators and Investigators

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

Sponsor

Sohag University

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)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-22-2-41

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

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.

Clinical Trials on Post Operative Pain

Clinical Trials on Ultrasound-Guided Transversus Abdominis Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe