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

Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: bupivacaine; Drug: Dexmedetomidine; Drug: clonidine; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.)	Drug: bupivacaine; bupivacaine 0.25% a total volume of 40 ml (20 ml each side; Other Names: Active Comparator; Drug: Dexmedetomidine; Dexmedetomidine 0.5 mcg/kg; Other Names: Active Comparator
ACTIVE_COMPARATOR: 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	Drug: bupivacaine; bupivacaine 0.25% a total volume of 40 ml (20 ml each side; Other Names: Active Comparator; Drug: clonidine; 1ug/kg clonidine; Other Names: Active Comparator
PLACEBO_COMPARATOR: bupivacaine and placebo; bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP	Drug: bupivacaine; bupivacaine 0.25% a total volume of 40 ml (20 ml each side; Other Names: Active Comparator; Drug: placebo; add placebo 9normal saline); Other Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time for first rescue analgesia after the TAP block	calculation the time needed for first rescue analgesia after the TAP block	24 hours post operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (ACTUAL): December 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Bupivacaine; Clonidine; Transversus Abdominis Plane Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Sympatholytics; Dexmedetomidine; Bupivacaine; Clonidine
• Other Study ID Numbers: aswu/182/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No