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NCT Number: NCT03770013

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: Active Comparator

Dexmedetomidine

Drug

Dexmedetomidine 0.5 mcg/kg

Other names: Active Comparator

Clonidine

Drug

1ug/kg clonidine

Other names: Active Comparator

Placebo

Drug

add placebo 9normal saline)

Other names: placebo comparator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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