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comparison between dexamethasone and dexmedetomidine as an adjunct to ropivacaine in post operative shoulder surgery

Phase 4
Recruiting
Conditions
healthy patients with ASA grade 1-2
Registration Number
CTRI/2015/08/006124
Lead Sponsor
Government Medical College and Hospital
Brief Summary

This study is a randomised ,double blind, single centre trial comparing the efficacy of dexamethasone and dexmedetomidine for post operative analgesia and cumulative total analgesic consumption when administered under ultrasound guidance as an adjunct to ropivacaine in interscalene block.it will be done in a period of 2 years in ASA 1 patients. pain will be assessed on basis of VAS score. Two groups will be studied , group 1 using .5 % ropivacaine 20 ml containing dexamethasone ( 8 mg ) to a total of 22 ml. group 2 using .5 % ropivacaine 20 ml with 2 ml of saline containg dexmedetomidine .5 mcg/kg to a total of 22 ml. Primary outcome will see the duration of postoperative analgsia, in minutes by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA. Secondary outcome will measure pain ratings over 24 hour on 0-100 VAS ,total postoperative analgesic consumption ,patient satisfaction and adverse effects.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
60
Inclusion Criteria
    1. ASA status 1-2 2. BMI.
  • 18-30 kg/m2 3. Shoulder surgery such as rotator cuff repair, recurrent shoulder dislocations, acromioplasty, hemiarthroplasty and total shoulder replacement.
Exclusion Criteria
  • patient refusing to give informed consent 2.
  • history of relevant drug allergy 3.
  • history of psychiatric illness, substance abuse 4.
  • severe cardiovascular, respiratory, metabolic or neurologic disease 5.
  • pregnancy and lactation 6.
  • coagulopathy 7.
  • contralateral phrenic nerve dysfunction 8.
  • infection at planned injection site 9.patients receiving alpha 2 agonists for hypertensive disorders 10.patients on steroids.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
duration of post-operative analgesia as measured ( in minutes ) by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCAo hour- time at which adequate sensory block is achieved | To time till the patient takes first dose of rescue analgesic( in 24 hours )
Secondary Outcome Measures
NameTimeMethod
pain ratings over 24 hours on 0-100 VAS , total post-operative analgesic consumption, patient satisfaction and adverse effects.2 hourly monitoring after 4 hours of nerve block upto 24 hours .

Trial Locations

Locations (1)

Government Medical College and Hospital, sector 32, chandigarh

🇮🇳

Chandigarh, CHANDIGARH, India

Government Medical College and Hospital, sector 32, chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Dr Sukanya Mitra
Principal investigator
9646121521
drsmitra12@yahoo.com

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