Actively Recruiting
Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
Led by Tanta University · Updated on 2025-09-16
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pain relief effects of two different methods, the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine, in women undergoing cesarean section. Cesarean section is a common major surgery often performed under spinal anesthesia, which can cause side effects like low blood pressure. Dexmedetomidine is a medication that acts on certain receptors to reduce pain, while the TFP block uses local anesthetic injected near specific nerves to block pain signals in the abdomen. Participants will receive spinal anesthesia with either a bilateral TFP block using bupivacaine injected at the end of surgery, or spinal anesthesia combined with intrathecal dexmedetomidine and a sham block. The TFP block group receives 2.5 mL of hyperbaric bupivacaine 0.5% spinally plus 20 mL of bupivacaine 0.25% in the TFP block. The dexmedetomidine group receives the same spinal anesthetic plus 5 micrograms of intrathecal dexmedetomidine diluted in saline with a sham block. Throughout the study, participants' pain levels will be assessed 24 hours after surgery as the main outcome. Researchers will also monitor total morphine use, time to first additional pain medication, blood pressure, heart rate during surgery, and any adverse events within 24 hours. The study includes adult women aged 18 to 40 undergoing cesarean section under spinal anesthesia. Participation involves monitoring and assessments during and after surgery with follow-up on pain and vital signs for one day.
CONDITIONS
Brief Title
Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 40 years
- American Society of Anesthesiology (ASA) physical status II
- Women undergoing cesarean section under spinal anesthesia
You will not qualify if you...
- Contraindication to spinal anesthesia
- Body mass index greater than 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours
Participants undergo cesarean section with spinal anesthesia combined with either transversalis fascia plane block or intrathecal dexmedetomidine at the end of surgery. Monitoring of vital signs occurs until the end of surgery.
1 surgical visit (in-person)
Duration - 24 hours postoperatively
Participants are monitored for pain levels, morphine consumption, time to first rescue analgesia, and adverse events after surgery.
Approximately 1 follow-up visit within 24 hours
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
M
Mohammed S ElSharkawy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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