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

• ClinicalTrials.gov Identifier: NCT03770013
• Recruitment Status: Completed
• First Posted: December 10, 2018
• Last Update Posted: August 5, 2020
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): hany farouk, Aswan University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: bupivacaine; Drug: Dexmedetomidine; Drug: clonidine; Drug: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective Randomized Interventional double-blind study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double-blind study.
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

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 Name: Active Comparator; Drug: Dexmedetomidine; Dexmedetomidine 0.5 mcg/kg; Other Name: 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 Name: Active Comparator; Drug: clonidine; 1ug/kg clonidine; Other Name: 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 Name: Active Comparator; Drug: placebo; add placebo 9normal saline); Other Name: placebo comparator

Outcome Measures

Primary Outcome Measures :

1. The time for first rescue analgesia after the TAP block [ Time Frame: 24 hours post operative ]
   calculation the time needed for first rescue analgesia after the TAP block

Secondary Outcome Measures :

1. Total dose of rescue analgesia [ Time Frame: 24 hours postoperative ]
   calculation of Total dose of rescue analgesia required in 24 h post-operatively
2. Adverse effects [ Time Frame: 24 hours postoperative ]
   Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Patients Undergoing Elective Caesarean Section.
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Aswan University

Aswan, Egypt, 81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

• Principal Investigator: hany f sallam, md; Aswan University Hospital

More Information

• Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT03770013
• Other Study ID Numbers: aswu/182/18
• First Posted: December 10, 2018
• Last Update Posted: August 5, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:

Bupivacaine; Dexmedetomidine; Clonidine; Transversus Abdominis Plane Block

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Clonidine; Dexmedetomidine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Hypnotics and Sedatives; Analgesics, Non-Narcotic; Analgesics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Sympatholytics; Autonomic Agents