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

October 9, 2018 updated by: Parineeta Thapa, B.P. Koirala Institute of Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Koshi
      • Dharān Bāzār, Koshi, Nepal, 56700
        • B. P. Koirala Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 3 minutes until 45 minutes after injection of drug
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.
every 3 minutes until 45 minutes after injection of drug
Duration of analgesia
Time Frame: Up to 24 hours after onset of block
Up to 24 hours after onset of block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 hours after onset of block
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
Up to 24 hours after onset of block
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
Forty-eight hours following the injection of local anesthetics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Principal Investigator: Parineeta Thapa, MD, BPKIHS, Dharan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

May 14, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC/641/015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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