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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Ropivacaine and Normal saline

Intervention Type DRUG

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline

Block with Ropivacaine and Dexamethasone

Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml

Group Type ACTIVE_COMPARATOR

Ropivacaine and Dexamethasone

Intervention Type DRUG

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone

Block with Ropivacaine and Dexmedetomidine

Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml

Group Type EXPERIMENTAL

Ropivacaine and Dexmedetomidine

Intervention Type DRUG

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine

Interventions

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Ropivacaine and Normal saline

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline

Intervention Type DRUG

Ropivacaine and Dexamethasone

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone

Intervention Type DRUG

Ropivacaine and Dexmedetomidine

Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No