NCT07170267

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 6, 2025

Last Update Submit

September 13, 2025

Conditions

Transversalis Fascia Plane BlockIntrathecal DexmedetomidineCesarean Section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Total morphine consumption

    24 hours postoperatively

  • Time to the 1st rescue analgesia

    24 hours postoperatively

  • Mean arterial pressure

    Till the end of surgery (Up to 2 hours)

  • Heart rate

    Till the end of surgery (Up to 2 hours)

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (2)

TFP group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Transversalis fascia plane blockOTHER

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.

TFP group
Intrathecal dexmedetomidineDRUG

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.

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohammed S ElSharkawy, MD

CONTACT

00201148207870mselsharkawy@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 12, 2025

Study Start

September 13, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)