Clinical trial NCT06944912: Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section
Official title: Combined Transversalis Fascia and Transversus Abdominis Plane Blocks Versus Intrathecal Morphine: Effects on Postoperative Opioid Consumption and Obstetric Recovery After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Obstetric Quality of Recovery-10 (ObsQoR-10) Score
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: Postoperative 24. hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Hospital
state: Yakutiye
Study officials:
affiliation: Atatürk University, Faculty of Medicine, Department of Anesthesiology and Reanimation
name: Ali Ahiskalioglu, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.