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RecruitingNCT07170267Updated Sep 16, 2025

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

An interventional study of Transversalis fascia plane block and Intrathecal dexmedetomidine in Transversalis Fascia Plane Block, Intrathecal Dexmedetomidine and Cesarean Section, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Transversalis Fascia Plane Block
  • Intrathecal Dexmedetomidine
  • Cesarean Section
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherTransversalis 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.

  • DrugIntrathecal 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.

06

What researchers measure

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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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.

    Time frame: 24 hours postoperatively

  2. 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.

    Time frame: 24 hours postoperatively

  3. Mean arterial pressure

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

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

  4. Heart rate

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

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

  5. Incidence of adverse events

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

    Time frame: 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07170267
Lead sponsor
Tanta University
Responsible party
Mohammed Said ElSharkawy (Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Sep 12, 2025
Start date
Sep 13, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Sep 16, 2025

Study contacts

Mohammed S ElSharkawy, MD
Contact
mselsharkawy@med.tanta.edu.eg
00201148207870

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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