Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: bupivacaine; Drug: placebo; Drug: Dexmedetomidine; Drug: clonidine

• Registration Number: NCT03770013
• Lead Sponsor: Aswan University Hospital

Brief Summary

Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

* Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)

* Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP

* Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.

Detailed Description

Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2019-01-01
• Primary Completion: 2020-06-30
• Status Verified: 2020-08
• Study Completion: 2020-08-01
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• parturients scheduled to undergo cesarean section under spinal anesthesia

Exclusion Criteria

• Patients who refused spinal anesthesia
• women with chronic pelvic pain or on chronic morphine use
• history of drug allergy
• coagulation disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine and placebo	placebo	bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
bupivacaine 0.25% and Dexmedetomidine	bupivacaine	bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
bupivacaine 0.25% and Dexmedetomidine	Dexmedetomidine	bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
bupivacaine and placebo	bupivacaine	bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP
bupivacaine and clonidine	bupivacaine	20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
bupivacaine and clonidine	clonidine	20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP

Primary Outcome Measures

Name	Time	Method
The time for first rescue analgesia after the TAP block	24 hours post operative	calculation the time needed for first rescue analgesia after the TAP block

Secondary Outcome Measures

Name	Time	Method
Total dose of rescue analgesia	24 hours postoperative	calculation of Total dose of rescue analgesia required in 24 h post-operatively
Adverse effects	24 hours postoperative	Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt