Transversalis fascia plane block versus intrathecal dexmedetomidine for pain after cesarean section
Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
This will try whether an ultrasound-guided transversalis fascia plane (TFP) nerve block or injecting dexmedetomidine into the spinal fluid gives better pain relief for women having a cesarean under spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07170267 on ClinicalTrials.gov |
What this trial studies
Women undergoing cesarean delivery with spinal anesthesia will receive either an ultrasound-guided transversalis fascia plane (TFP) block targeting the proximal T12–L1 branches or intrathecal dexmedetomidine added to the spinal anesthetic to compare postoperative analgesia and safety. Pain scores, opioid consumption, hemodynamic effects (including hypotension), and recovery parameters will be recorded after surgery. The TFP block delivers local anesthetic into the plane between the transversus abdominis muscle and the transversalis fascia under ultrasound guidance, while intrathecal dexmedetomidine is administered into the cerebrospinal fluid as an adjuvant to spinal anesthesia. Patients with contraindications such as coagulation abnormalities, major cardiovascular disease, BMI >40 kg/m2, or pregnancy complications requiring general anesthesia are excluded.
Who should consider this trial
Good fit: Women aged 18–40 years with ASA physical status II scheduled for cesarean section under spinal anesthesia and meeting the listed inclusion/exclusion criteria would be appropriate candidates.
Not a fit: Patients with contraindications to spinal anesthesia, known cardiovascular disease, coagulation abnormalities, BMI over 40 kg/m2, pregnancy complications requiring conversion to general anesthesia, chronic pain, or substance abuse are unlikely to be eligible or to gain benefit from participation.
Why it matters
Potential benefit: If successful, one of these approaches could offer better postoperative pain control with reduced opioid use and fewer side effects after cesarean delivery.
How similar studies have performed: Previous trials have shown that intrathecal dexmedetomidine and various abdominal interfascial plane blocks can reduce post-cesarean pain and opioid needs, but direct head-to-head data comparing TFP block specifically to intrathecal dexmedetomidine are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S ElSharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.