TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

October 12, 2023 updated by: Universitas Padjadjaran

Comparison of Post-operative Analgetics With Transversus Abdominis Block and Spinal Morphine for Post-Caesarean Section: A Randomised Trial Study

The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are:

  • Which post op analgesic method works better for patients who underwent caesarean section
  • The number of additional opioid needed

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

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

  • Indonesia
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40161
        • Hasan Sadikin General 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Indicated for caesarean section as assessed by Obstetricians
  • ASA II
  • Consented to be included in the study

Exclusion Criteria:

  • Allergy history
  • Spinal converted to general anesthesia

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transversus Abdominis Plane Block
Twenty two subjects were given postoperative block administration in the transversus abdominis area on each side with ultrasonography (USG) guidance
Procedure: Transversus Abdominal Plane Block
20 cc of bupivacaine 0.2% was given to the transversus abdominis plane
Active Comparator: Spinal Morphine
Twenty two subjects were given additional morphine 100 µg intrathecally
Procedure: Spinal Morphine
100 µg was administered intrathecally preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time the patient needed the first additional opioid analgesics
Time Frame: 24 hours post operative
24 hours post operative
Total need for additional opioids
Time Frame: 24 hours post operative
24 hours post operative

Collaborators and Investigators

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

Sponsor

Universitas Padjadjaran

Investigators

  • Study Director: Osmond M Pison, MD, Faculty of Medicine Universitas Padjadjaran Bandung
  • Principal Investigator: Mohammad F Maulana, MD, Faculty of Medicine Universitas Padjadjaran Bandung
  • Study Director: Suwarman, MD, Faculty of Medicine Universitas Padjadjaran Bandung
  • Study Director: Prapanca Nugraha, MD, Faculty of Medicine Universitas Padjadjaran Bandung

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)

February 23, 2023

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-202310.01

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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