Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section

NCT ID: NCT06386978

Last Updated: 2025-12-23

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2025-12-15

Brief Summary

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This study was designed as a prospective, randomized observational clinical trial.

A total of 90 adult women were included in the study performed elective cesarean section.

After excluding patients, the care of 90 was included and 3 of these amounts were reserved.

TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;

Detailed Description

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This study was designed as a prospective, randomized observational clinical trial. Erciyes University Clinical Research Ethics Board 2024/209.

All participants in the study were adults and their information was confirmed in writing. Preoperative anesthesia assessment was made by an anesthetic injection, cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025. ASA score, anesthesia method, age, weight, height, TAP block group (Group I) or TFP block group (Group II), Control group (Group III) :

Duration of spinal anesthesia, time of first analgesic request, total analgesic consumption for 24-48 hours, VAS score, additional analgesics, patient satisfaction, possible postoperative bleeding, vomiting, heat retention and other interruptions were recorded in the patients.

Those who were allergic to local anesthetics, steroid treatment areas, ASA III, ASA IV and ASA V, patients under the age of 18, preeclampsia, eclampsia, placenta percreta and accreta complications and emergency hospitals were excluded from the study. After excluding patients, the care of 90 was included and 3 of these amounts were reserved.

TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3): Spinal Anesthesia + No block; At the end of the surgery, TAP (Transverse Abdominis Plane Block) Block or TFP (Transversalis Fascia Plane Block) block was performed under aseptic conditions under ultrasonography guidance.

TAP (Transverse Abdominis Plane Block) Block for Group 1 patients and TFP (Transversalis Fascia Plane Block) block for Group 2 patients on both sides after negative aspiration, with 20 ml 0.25% bupivacaine (Marcaine®, Astra-Zeneca, Turkey) under ultrasonography guidance. It was done under aseptic conditions.

Patients who did not accept both blocks were included in Group 3 (Control group).

All patients were trained on visual analog score (VAS) by the anesthesia assistant during the preoperative evaluation. VAS used for pain assessment, a 10 cm long horizontal line was used.

From 0= (no pain) to 10= (most severe pain).

PCA morphine administration to all patients: The hourly limit was set as 4 mg, and the repeat limit was set as 10 minutes. If the 1 mg IV morphine bolus dose was not sufficient, it was planned to repeat it after 10 minutes, and if it was still not sufficient, paracetamol and diclofenac were planned to be administered.

Conditions

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Obstetric

Keywords

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ceserean section transverse abdominis plane block transversalis facia plane block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TAP Group

TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.

Group Type ACTIVE_COMPARATOR

Transverse Facia Plane Block (TAP Block)

Intervention Type PROCEDURE

Spinal Anesthesia + TAP block

TFP Group

TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.

Group Type ACTIVE_COMPARATOR

Transversalis Facia Plane Block (TFP Block)

Intervention Type PROCEDURE

Spinal Anesthesia + TFP block

Control Group

Patients in the Third group will be considered the control group and no block will be performed

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

Spinal anesthesia + No block

Interventions

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Transverse Facia Plane Block (TAP Block)

Spinal Anesthesia + TAP block

Intervention Type PROCEDURE

Transversalis Facia Plane Block (TFP Block)

Spinal Anesthesia + TFP block

Intervention Type PROCEDURE

Control

Spinal anesthesia + No block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I and ASA II,
* Pregnant patients accepting spinal anesthesia and procedure

Exclusion Criteria

* Those who are allergic to local anesthetics,
* Those receiving steroid treatment,
* ASA III, ASA IV and ASA V,
* Patients under the age of 18,
* Patients with preeclampsia,
* Eclampsia,
* Placenta percreta and accreta and its complications,
* Emergency patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Kudret Dogru

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kudret Dogru, Prof.

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, Jagar KD, Gupta M. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial. Saudi J Anaesth. 2015 Jul-Sep;9(3):298-302. doi: 10.4103/1658-354X.154732.

Reference Type BACKGROUND
PMID: 26240550 (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 BACKGROUND
PMID: 32412986 (View on PubMed)

Other Identifiers

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2024/209

Identifier Type: -

Identifier Source: org_study_id