Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section

November 20, 2019 updated by: Ali Ahiskalioglu, Ataturk University

Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study

Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Turkey
      • Erzurum, Turkey, 25100
        • Ali Ahıskalıoğlu

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:

  • aged between 18 and 45
  • American Society of Anesthesiologists (ASA) physical score I or II

Exclusion Criteria:

  • Patients who received general anesthesia
  • hypersensitivity to the agents to be used
  • body mass index (BMI) greater than 35 kg/m2
  • coagulopathy
  • local infections
  • opioid addiction
  • pregnancy-related hypertension or diabetes mellitus

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: ultrasound guided transversalis fascia plane block
20 mL of 0.25% bupivacaine
Drug: Bupivacaine Hcl 0.25% Inj
ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine
Placebo Comparator: ultrasound guided sham block
20 mL of saline
Drug: saline 0.9%
ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: Postoperative first 24hour
morphine consumption first 24hour
Postoperative first 24hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: postoperative 0-24 hours
Visual Analogue Scale (0-10)
postoperative 0-24 hours

Collaborators and Investigators

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

Sponsor

Ataturk University

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 (Actual)

January 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTF ANESTHESIAOBSTETRIC

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.

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