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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Transversalis Fascia Plane Block; Intrathecal Dexmedetomidine
• Intervention / Treatment: Other: Transversalis fascia plane block; Drug: Intrathecal dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Principal Investigator: Saad A Moharam, MD
      • Contact: Mohammed S Elsharkawy, MD; Phone Number: 00201148207870; Email: mselsharkawy@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TFP group; 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.	Other: 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.
Active Comparator: Control group; 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	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.	24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 6, 2025
• First Submitted That Met QC Criteria: September 6, 2025
• First Posted (Estimated): September 12, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36264PR1335/8/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No