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

Not Applicable

Not yet recruiting

• Conditions: Transversalis Fascia Plane Block; Intrathecal Dexmedetomidine; Cesarean Section
• Interventions: Other: Transversalis fascia plane block; Drug: Intrathecal dexmedetomidine

• Registration Number: NCT07170267
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-06
• Study First Submitted QC: 2025-09-06
• Last Update Submitted: 2025-09-06
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-09-15
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TFP group	Transversalis fascia plane block	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.
Control group	Intrathecal dexmedetomidine	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 Outcome Measures

Name	Time	Method
Degree of pain	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 Outcome Measures

Name	Time	Method
Total morphine consumption	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.
Time to the 1st rescue analgesia	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.
Mean arterial pressure	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.
Heart rate	Till the end of surgery (Up to 2 hours)	Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt