Clinical trial NCT02787018: Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
Official title: Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brachial Plexus Block
Keywords: Brachial plexus block
Ropivacaine
Dexmedetomidine
Dexamethasone
Adjuvants, anesthesia
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Onset of sensory block
timeFrame: every 3 minutes until 45 minutes after injection of drug
measure: Onset of motor block
timeFrame: every 3 minutes until 45 minutes after injection of drug
measure: Duration of analgesia
timeFrame: Up to 24 hours after onset of block
Secondary outcomes:
measure: Duration of sensory block
timeFrame: Up to 24 hours after onset of block
measure: Duration of motor block
timeFrame: Up to 24 hours after onset of block
measure: Incidence of side effects of drugs
timeFrame: Forty-eight hours following the injection of local anesthetics
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B. P. Koirala Institute of Health Sciences
state: Koshi
Study officials:
affiliation: BPKIHS, Dharan
name: Parineeta Thapa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.