search
Back to results

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

Primary Purpose

Caesarean Section, Pain, Acute

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Hcl 0.25% Inj
saline 0.9%
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caesarean Section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ali Ahıskalıoğlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ultrasound guided transversalis fascia plane block

ultrasound guided sham block

Arm Description

20 mL of 0.25% bupivacaine

20 mL of saline

Outcomes

Primary Outcome Measures

opioid consumption
morphine consumption first 24hour

Secondary Outcome Measures

pain scores
Visual Analogue Scale (0-10)

Full Information

First Posted
November 20, 2019
Last Updated
November 20, 2019
Sponsor
Ataturk University
search

1. Study Identification

Unique Protocol Identification Number
NCT04172727
Brief Title
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section
Official Title
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Section, Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided transversalis fascia plane block
Arm Type
Active Comparator
Arm Description
20 mL of 0.25% bupivacaine
Arm Title
ultrasound guided sham block
Arm Type
Placebo Comparator
Arm Description
20 mL of saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.25% Inj
Intervention Description
ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
saline 0.9%
Intervention Description
ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%
Primary Outcome Measure Information:
Title
opioid consumption
Description
morphine consumption first 24hour
Time Frame
Postoperative first 24hour
Secondary Outcome Measure Information:
Title
pain scores
Description
Visual Analogue Scale (0-10)
Time Frame
postoperative 0-24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women aged between 18 and 45 with American Society of Anesthesiologists (ASA) physical score I or II undergoing elective CS
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ali Ahıskalıoğlu
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31255890
Citation
Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.
Results Reference
background
PubMed Identifier
19495909
Citation
Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
Results Reference
background
PubMed Identifier
32412986
Citation
Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs