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Trial record 68 of 326 for:    clonidine

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

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ClinicalTrials.gov Identifier: NCT03770013
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770013


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, md    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03770013     History of Changes
Other Study ID Numbers: aswu/182/18
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Clonidine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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