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

NCT ID: NCT03770013

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-08-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

bupivacaine 0.25% and 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.)

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

bupivacaine 0.25% a total volume of 40 ml (20 ml each side

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine 0.5 mcg/kg

bupivacaine and clonidine

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

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

bupivacaine 0.25% a total volume of 40 ml (20 ml each side

clonidine

Intervention Type: DRUG

1ug/kg clonidine

bupivacaine and placebo

bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP

Group Type: PLACEBO_COMPARATOR

bupivacaine

Intervention Type: DRUG

bupivacaine 0.25% a total volume of 40 ml (20 ml each side

placebo

Intervention Type: DRUG

add placebo 9normal saline)

Interventions

bupivacaine

bupivacaine 0.25% a total volume of 40 ml (20 ml each side

Intervention Type: DRUG

Dexmedetomidine

Dexmedetomidine 0.5 mcg/kg

Intervention Type: DRUG

clonidine

1ug/kg clonidine

Intervention Type: DRUG

placebo

add placebo 9normal saline)

Intervention Type: DRUG

Other Intervention Names

Active Comparator; Active Comparator; Active Comparator; placebo comparator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/182/18

Identifier Type: -

Identifier Source: org_study_id