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

NCT02787018 | Completed Phase 3

• 1 other identifier: IRC/641/015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Plexus Block

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Onset of sensory block

  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

  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

  Up to 24 hours after onset of block

Secondary Outcomes (3)

• Duration of sensory block

  Up to 24 hours after onset of block

• Duration of motor block

  Up to 24 hours after onset of block

• Incidence of side effects of drugs

  Forty-eight hours following the injection of local anesthetics

Study Arms (3)

Block with Ropivacaine and Normal saline

PLACEBO COMPARATOR

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

Block with Ropivacaine and Dexamethasone

ACTIVE COMPARATOR

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

Drug: Ropivacaine and Dexamethasone

Block with Ropivacaine and Dexmedetomidine

EXPERIMENTAL

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

Drug: Ropivacaine and Dexmedetomidine

Interventions

Ropivacaine and Normal saline DRUG

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

Block with Ropivacaine and Normal saline

Ropivacaine and Dexamethasone DRUG

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

Block with Ropivacaine and Dexamethasone

Ropivacaine and Dexmedetomidine DRUG

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

Block with Ropivacaine and Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B. P. Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

Location

Related Publications (4)

• Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.

  PMID: 24413428 BACKGROUND

• Das A, Majumdar S, Halder S, Chattopadhyay S, Pal S, Kundu R, Mandal SK, Chattopadhyay S. Effect of dexmedetomidine as adjuvant in ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded and randomized controlled study. Saudi J Anaesth. 2014 Nov;8(Suppl 1):S72-7. doi: 10.4103/1658-354X.144082.

  PMID: 25538527 BACKGROUND

• Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014 May-Aug;8(2):202-8. doi: 10.4103/0259-1162.134506.

  PMID: 25886227 BACKGROUND

• Zhang Y, Wang CS, Shi JH, Sun B, Liu SJ, Li P, Li EY. Perineural administration of dexmedetomidine in combination with ropivacaine prolongs axillary brachial plexus block. Int J Clin Exp Med. 2014 Mar 15;7(3):680-5. eCollection 2014.

  PMID: 24753763 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Saline Solution; Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Parineeta Thapa, MD

  BPKIHS, Dharan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

NE (1)