To compare the effectiveness of a local anaesthetic(Ropivacaine) and the same drug with an adjuvant (Dexmedetomidine) as an anaesthesia technique given around nerve bundle above the collar bone for arm surgeries using ultrasound guidance
- Conditions
- Injuries to the elbow and forearm, (2) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers,
- Registration Number
- CTRI/2018/12/016701
- Lead Sponsor
- Department of Anaesthesiology
- Brief Summary
This is a double blinded randomized controlled trial to assess the efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in ultrasound guided brachial plexus block for upper limb surgeries. Sample size was calculated by n- master software versiov 2.0. With power of 80% and alpha error of 5%, the sample size required is 30 in each group. To account for drop outs, the sample size was taken as 35 in each group. Randomisation was done by computer generated permuted block randomisation. Control group C (n= 35) will receive 29 ml 0.75% Ropivacaine+ 1 ml normal saline and study group D (n=35) will receive 29 ml 0.75% Ropivacaine+ Dexmedetomidine 50mcg( 0.5ml)+0.5 ml normal saline, to a total volume of30 ml in each group. Parameters assessed- onset of sensory block,duration of sensory block, onset of motor block, duration of motor block, duration of analgesia,hemodynamic parameters, sedation and adverse effects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 60
ASA physical status 1 and 2, of either gender between 18 and 70 years of age for upper limb surgeries below mid humerus.
morbid obesity, coagulopathy, uncontrolled diabetes mellitus, peripheral vascular disease, neurological disease, known allergy to local anaesthetics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dexmedetomidine added to Ropivacaine prolongs the duration of analgesia, in hastening and prolonging sensory and motor block when compared to Ropivacaine alone in supraclavicular brachial plexus block for upper limb surgeries Hemodynamic parameters,sensory and motor block, analgesia are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved
- Secondary Outcome Measures
Name Time Method Dexmedetomidine added to Ropivacaine is safer when compared to Ropivacaine alone in supraclavicular brachialplexus block for upper limb surgeries Adverse effects are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved
Trial Locations
- Locations (1)
Malankara Orthodox Syrian Church medical college
🇮🇳Ernakulam, KERALA, India
Malankara Orthodox Syrian Church medical college🇮🇳Ernakulam, KERALA, IndiaKeerthi CPrincipal investigator9446392194keerthi.kausthubham@gmail.com