Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section

NCT06944912 | Completed DMC

• 1 other identifier: AUTFTAPTFP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ceserean Section and Postoperative Pain

Keywords

Postoperative Recovery; Cesarean Section; Postoperative Pain; Transversalis Fascia Plane Block; Transversus Abdominis Plane Block; Intrathecal Opioid; ObsQoR-10 T

Outcome Measures

Primary Outcomes (1)

• The Obstetric Quality of Recovery-10 (ObsQoR-10) Score

  The questionnaire's subscales are physical comfort (n=3 items), emotional state (n=2 items), pain (n=1 item), physical independence (n=2 items), and the ability to take care of the newborn (n=2 items). Each item is scored on a scale of 0-10, except for the first four items, which are graduated from 10 to 0. The total score is the sum of all item scores (i.e. a score ranging from 0 to 100, where 0 is the worst recovery score, and 100 indicates the best).

  Postoperative 24 hours

Secondary Outcomes (1)

• Opioid consumption

  Postoperative 24. hours

Study Arms (2)

Transversalis fascia+Transversus abominis plane block

ACTIVE COMPARATOR

Procedure: Transversalis fascia plane block and transversus abdominis plane block

Intrathecal Morphine

ACTIVE COMPARATOR

Procedure: Intrathecal Morphine

Interventions

Transversalis fascia plane block and transversus abdominis plane block PROCEDURE

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

Transversalis fascia+Transversus abominis plane block

Intrathecal Morphine PROCEDURE

100 mcg morphine with local anesthetics injected intrathecally

Intrathecal Morphine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• American Society of Anesthesiologists physical score I or II
• caesarean section with a Pfannenstiel incision

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 39039833 RESULT

• 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.

  PMID: 32412986 RESULT

• Cadirci DY, Aydin ME, Ahiskalioglu EO, Celik EC, Yayik AM, Coruh S, Senocak GNC, Ciftci B, Ahiskalioglu A. Intrathecal morphine versus transversalis fascia and transversus abdominis plane blocks combination on obstetric quality of recovery after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 17. doi: 10.1186/s12871-025-03559-0. Online ahead of print.

  PMID: 41408168 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ali Ahiskalioglu, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

TU (1)