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OpenTrials
Completed

NCT Number: NCT06944912

Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Intrathecal Morphine

Procedure

100 mcg morphine with local anesthetics injected intrathecally

Primary outcomes

  1. The Obstetric Quality of Recovery-10 (ObsQoR-10) Score

    Time frame: Postoperative 24 hours

    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).

Secondary outcomes

  1. Opioid consumption

    Time frame: Postoperative 24. hours

    Patient controlled analgesia based opioid requirement

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Combined Transversalis Fascia and Transversus Abdominis Plane Blocks Versus Intrathecal Morphine: Effects on Postoperative Opioid Consumption and Obstetric Recovery After Cesarean Section

Acronym: TAPTFPB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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