Comparison of the Quality of Recovery After Cesarean Section Surgery

August 18, 2023 updated by: Melike Korkmaz Toker, Muğla Sıtkı Koçman University

Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery

Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

  • Name: Melike Korkmaz Toker, Associate Professor
  • Phone Number: 00905054747098
  • Email: meltoker@gmail.com

Study Locations

  • Turkey
      • Mugla, Turkey
        • Mugla Sıtkı Kocman University Training and Research Hospital
        • Contact:

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

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status II-III
  • Cesarean section surgery under spinal anesthesia

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV
  • Emergency surgery
  • General anesthesia
  • Additional surgical intervention at the same session
  • Body mass index of more than 35 kg/m2
  • Allergy to any study drugs
  • Local infection at the injection site
  • History of drug abuse
  • Communication problem
  • Coagulopathy
  • Preeclampsia and eclampsia

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
Active Comparator: Transversus Abdominis Plane (TAP) Block Group
At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.
Procedure: Transversus Abdominis Plane Block
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally
Active Comparator: Transversalis Fascia Plane Block (TFPB) Group
At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.
Procedure: Transversalis Fascia Plane Block
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative quality of recovery
Time Frame: Postoperative 24th hour
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
Postoperative 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Numeric Rating Scale
Time Frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Adverse Reactions
Time Frame: Postoperative 24th hour
Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed
Postoperative 24th hour

Collaborators and Investigators

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

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Melike Korkmaz Toker, Associate Professor, Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation

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 (Estimated)

August 24, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 2, 2023

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSKU 13-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

via mail

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 Abdominal Pain

Clinical Trials on Transversalis Fascia Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe