Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787018
Enrollment
120
Registered
2016-06-01
Start date
2016-06-30
Completion date
2018-09-30
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Block

Keywords

Brachial plexus block, Ropivacaine, Dexmedetomidine, Dexamethasone, Adjuvants, anesthesia

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.

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.

Interventions

DRUGRopivacaine and Normal saline

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

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

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

Sponsors

B.P. Koirala Institute of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Onset of sensory blockevery 3 minutes until 45 minutes after injection of drugSensory 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.
Onset of motor blockevery 3 minutes until 45 minutes after injection of drugMotor 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.
Duration of analgesiaUp to 24 hours after onset of block

Secondary

MeasureTime frameDescription
Duration of sensory blockUp to 24 hours after onset of blocktime from onset of sensory block to complete recovery of anaesthesia on all nerves.
Duration of motor blockUp to 24 hours after onset of blocktime from onset of motor block to the recovery of complete motor function of the hand and forearm
Incidence of side effects of drugsForty-eight hours following the injection of local anestheticsSide effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026