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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2018

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

  • Drug: Ropivacaine and Normal saline
    • Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline
  • Drug: Ropivacaine and Dexamethasone
    • Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone
  • Drug: Ropivacaine and Dexmedetomidine
    • Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • Duration of analgesia
    • Time Frame: Up to 24 hours after onset of block

Secondary Measures

  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • B.P. Koirala Institute of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Parineeta Thapa, Dr – B.P. Koirala Institute of Health Sciences
  • Overall Official(s)
    • Parineeta Thapa, MD, Principal Investigator, BPKIHS, Dharan

References

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.

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.

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.

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.

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