Analgesic Efficacy of Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Degree of pain
Study Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- 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
- •Contraindication to spinal anesthesia.
- •Women with body mass index >40 kg/m
- •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.
Arms & Interventions
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.
Intervention: Transversalis fascia plane block (Other)
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.
Intervention: Intrathecal dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Degree of pain
Time Frame: 24 hours postoperatively
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.
Secondary Outcomes
- 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)
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University