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Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

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ClinicalTrials.gov Identifier: NCT02787018
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Parineeta Thapa, B.P. Koirala Institute of Health Sciences

Brief Summary:
The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Condition or disease Intervention/treatment Phase
Brachial Plexus Block Drug: Ropivacaine and Normal saline Drug: Ropivacaine and Dexamethasone Drug: Ropivacaine and Dexmedetomidine Phase 3

Detailed Description:
Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
Study Start Date : June 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018


Arm Intervention/treatment
Placebo Comparator: Block with Ropivacaine and Normal saline
Patients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml
Drug: Ropivacaine and Normal saline
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline

Active Comparator: Block with Ropivacaine and Dexamethasone
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml
Drug: Ropivacaine and Dexamethasone
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone

Experimental: Block with Ropivacaine and Dexmedetomidine
Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml
Drug: Ropivacaine and Dexmedetomidine
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine




Primary Outcome Measures :
  1. Onset of sensory block [ Time Frame: every 3 minutes until 45 minutes after injection of drug ]

    Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale:

    0 - normal sensation,

    1. - loss of sensation of pinprick (analgesia),
    2. - loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories.

  2. Onset of motor block [ Time Frame: every 3 minutes until 45 minutes after injection of drug ]

    Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function:

    0 - normal motor function,

    1. - reduced motor strength but able to move,
    2. - complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories.

  3. Duration of analgesia [ Time Frame: Up to 24 hours after onset of block ]

Secondary Outcome Measures :
  1. Duration of sensory block [ Time Frame: Up to 24 hours after onset of block ]
    time from onset of sensory block to complete recovery of anaesthesia on all nerves.

  2. Duration of motor block [ Time Frame: Up to 24 hours after onset of block ]
    time from onset of motor block to the recovery of complete motor function of the hand and forearm

  3. Incidence of side effects of drugs [ Time Frame: Forty-eight hours following the injection of local anesthetics ]
    Side effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block

Exclusion Criteria:

  • Patient's refusal to participate
  • Patients weighing less than 40 kg
  • Allergy to study drugs
  • Infection at the site of injection
  • Patients with preexisting neurological deficit
  • Patients with diabetes mellitus
  • Patients on steroids preoperatively
  • Patients with bleeding disorder or coagulopathy
  • Abnormalities in ECG like AV block or symptomatic bradycardia
  • Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively
  • Requirement of conversion to general anesthesia due to inadequate block

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): NCT02787018


Locations
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Nepal
B. P. Koirala Institute of Health Sciences
Dharān Bāzār, Koshi, Nepal, 56700
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
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Principal Investigator: Parineeta Thapa, MD BPKIHS, Dharan
Publications:
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Responsible Party: Parineeta Thapa, Dr, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT02787018    
Other Study ID Numbers: IRC/641/015
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Parineeta Thapa, B.P. Koirala Institute of Health Sciences:
Brachial plexus block
Ropivacaine
Dexmedetomidine
Dexamethasone
Adjuvants, anesthesia
Additional relevant MeSH terms:
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Dexamethasone
Dexmedetomidine
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics