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Completed

NCT Number: NCT02787018

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

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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Key information

Conditions

Brachial Plexus Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

B. P. Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine and Normal saline

Drug

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

Ropivacaine and Dexamethasone

Drug

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

Ropivacaine and Dexmedetomidine

Drug

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

Primary outcomes

  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,

    • - loss of sensation of pinprick (analgesia),
    • - 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,

    • - reduced motor strength but able to move,
    • - 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2016
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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