Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transversalis fascia plane block, Intrathecal dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Transversalis Fascia Plane Block, Intrathecal Dexmedetomidine, Cesarean Section. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
Overview
This study aims to compare the analgesic efficacy of the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine in patients undergoing cesarean section (CS).
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.
Interventions
- 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. - 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.
Primary outcome measures
- Degree of pain [Time frame: 24 hours postoperatively]
Secondary outcome measures (5)
- Total morphine consumption [Time frame: 24 hours postoperatively]
- Time to the 1st rescue analgesia [Time frame: 24 hours postoperatively]
- Mean arterial pressure [Time frame: Till the end of surgery (Up to 2 hours)]
- Heart rate [Time frame: Till the end of surgery (Up to 2 hours)]
- Incidence of adverse events [Time frame: 24 hours postoperatively]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07170267 · 36264PR1335/8/25