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NCT Number: NCT07170267

Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section

This study aims to compare the analgesic efficacy of the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine in patients undergoing cesarean section (CS).

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Key information

Conditions

Transversalis Fascia Plane Block Cesarean Section Intrathecal Dexmedetomidine

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Mohammed S Elsharkawy, MD

CONTACT

[email protected]

00201148207870

Saad A Moharam, MD

PRINCIPAL_INVESTIGATOR

About this study

Cesarean section (CS) is a commonly performed major surgical procedure that results in substantial postoperative pain and patient dissatisfaction.

Spinal anesthesia is commonly used in CS surgery. However, it may be associated with several side effects, particularly hypotension.

Dexmedetomidine is an α2 adrenergic receptor agonist that has an analgesic effect.

Ultrasound-guided interfascial plane blocks are often used in multimodal analgesia regimens. Local anaesthetic injection into the transversalis fascia plane (TFP) anesthetizes the proximal branches of T12 and L1 which targeted in the plane between the transversus abdominis muscle and the transversalis fascia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 40 years.
  • American Society of Anesthesiology (ASA) physical status II.
  • Women undergoing cesarean section under spinal anesthesia.

Exclusion criteria

  • Contraindication to spinal anesthesia.
  • Women with body mass index >40 kg/m2.
  • Pregnancy-induced hypertension
  • Local infection at the site of injection.
  • Known cardiovascular disease
  • Coagulation abnormality.
  • History of chronic pain.
  • Abuse of drugs or alcohol.
  • History of allergies to any study medications.
  • Seizure disorders.
  • Any pregnancy complications requiring conversion to general anesthesia.

Treatment and study plan

transversalis fascia plane block

Other

Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.

Intrathecal dexmedetomidine

Drug

Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) + (5 µg intrathecal dexmedetomidine diluted in 0.5ml saline) with a sham block at the end of surgery.

Primary outcomes

  1. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18 and 24 h postoperatively.

Secondary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.

  2. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated.

  3. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 2 hours)

    Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.

  4. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.

  5. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed S ElSharkawy, MD

CONTACT

[email protected]

00201148207870

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 16, 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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