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Ketamine Versus Dexmedetomidine in Supraclavicular Brachial Plexus Block

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ClinicalTrials.gov Identifier: NCT04508894
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
haidy salah mansour, Minia University

Brief Summary:

Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.

Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind


Condition or disease Intervention/treatment Phase
Supraclavicular Brachial Plexus Block Drug: Supraclavicular Brachial Plexus Block with bupivacaine Drug: Supraclavicular Brachial Plexus Block with Ketamine Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block
Actual Study Start Date : April 21, 2019
Estimated Primary Completion Date : December 28, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline
Drug: Supraclavicular Brachial Plexus Block with bupivacaine

drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Other Name: C group

Active Comparator: Ketamine group
Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine
Drug: Supraclavicular Brachial Plexus Block with Ketamine

drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Other Name: K group

Active Comparator: Dexmedetomidine group
Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine
Drug: Supraclavicular Brachial Plexus Block with Dexmedetomidine

drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.

Device: ultrasound-guided supraclavicular Brachial Plexus nerve block

Other Name: D group




Primary Outcome Measures :
  1. Evaluate duration of sensory block [ Time Frame: 24 hours after block ]
    Sensory block duration: the time interval between the complete sensory block and complete resolution by hours


Secondary Outcome Measures :
  1. Evaluate onset of sensory and motor block [ Time Frame: 30 minute after block ]
    Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min.

  2. Assess postoperative pain score [ Time Frame: For 24 hours after surgery ]
    The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAP) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain

  3. time to first analgesic request [ Time Frame: 24 hours ]
    Time for the first request to rescue analgesia (in hours)

  4. total analgesic requirements [ Time Frame: 24 hours after surgery ]
    Total diclofenac consumption requirements in 24 hours

  5. sedation score [ Time Frame: 24 hours after surgery ]
    Ramsay Sedation Scale from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 =sluggish response; 6 = no response



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Physical Status I or II
  • patients undergoing elective and emergency forearm and hand surgeries

Exclusion Criteria:

  • Patient with bleeding disorders
  • Damage or disease of the brachial plexus
  • Uncontrolled diabetes mellitus
  • Patients with neuromuscular diseases
  • Patients with a local skin infection at the site of injection
  • Patients with known hypersensitivity to studied drugs

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): NCT04508894


Contacts
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Contact: Haidy S Mansour, MD 01221802324 ext +2 haidy_mourad@yahoo.com

Locations
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Egypt
Minya University Recruiting
Minya, Egypt, 61519
Contact: Haidy S Mansour, MD    0122182324 ext +2    haidy_mourad@yahoo.com   
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Haidy S Mansour, MD assistant professor of Anesthesia and Surgical Intensive Care
  Study Documents (Full-Text)

Documents provided by haidy salah mansour, Minia University:
Study Protocol  [PDF] February 21, 2019

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Responsible Party: haidy salah mansour, Professor, Minia University
ClinicalTrials.gov Identifier: NCT04508894    
Other Study ID Numbers: 146:4/2019
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Ketamine
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
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents