Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section

NCT ID: NCT06944912

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-01

Brief Summary

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Cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. While intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. The transversus abdominis plane (TAP) block provides somatic pain relief but is often insufficient alone. The transversalis fascia plane block (TFPB) has been shown to enhance lower abdominal analgesia. This study aims to evaluate whether combining TAP and TFP blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.

Detailed Description

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Conditions

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Ceserean Section and Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transversalis fascia+Transversus abominis plane block

Group Type ACTIVE_COMPARATOR

Transversalis fascia plane block and transversus abdominis plane block

Intervention Type PROCEDURE

20 ml local anesthetics for Transversus Abdominis Plane block and 10 ml local anesthetics for Trasnversalis fascia plane block

Intrathecal Morphine

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type PROCEDURE

100 mcg morphine with local anesthetics injected intrathecally

Interventions

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Transversalis fascia plane block and transversus abdominis plane block

20 ml local anesthetics for Transversus Abdominis Plane block and 10 ml local anesthetics for Trasnversalis fascia plane block

Intervention Type PROCEDURE

Intrathecal Morphine

100 mcg morphine with local anesthetics injected intrathecally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-45 years old
* American Society of Anesthesiologists physical score I or II
* caesarean section with a Pfannenstiel incision

Exclusion Criteria

* additional surgical intervention, or received general anaesthesia,
* hypersensitivity to the agents to be used
* BMI greater than 35 kg m-2
* coagulopathy,
* local infection,
* opioid addiction,
* pregnancy-related hypertension
* diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ali Ahiskalioglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ahiskalioglu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Atatürk University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Locations

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Atatürk University Hospital

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.

Reference Type RESULT
PMID: 39039833 (View on PubMed)

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.

Reference Type RESULT
PMID: 32412986 (View on PubMed)

Other Identifiers

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AUTFTAPTFP

Identifier Type: -

Identifier Source: org_study_id

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