A comparative study of efficacy of ultrasound guided interscalene brachial plexus block with 0.2% ropivacaine vs 0.2% ropivacaine with dexmedetomidine on postoperative analgesia in patients undergoing shoulder surgery.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- To compare the analgesic efficacy of 0.2% ropivacaine versus 0.2% ropivacaine with dexmedetomidine in ultrasound guided interscalene brachial plexus block in patients undergoing shoulder surgeries
Study Overview
Brief Summary
It is a prospective, randomized, double-blinded comparative study to evaluate the efficacy of dexmedetomidine as an adjuvant to 0.2% ropivacaine in ultrasound-guided interscalene brachial plexus block for postoperative analgesia in patients undergoing shoulder surgery.
Parameters compared between the two groups will include duration of analgesia, onset and duration of sensory and motor block, postoperative pain scores (VAS), time to first rescue analgesia, sedation score, hemodynamic parameters, and incidence of adverse effects.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA grade I or II fit patients.
- •Ages between 18 and 65 years
- •Patients undergoing upper shoulder surgeries under General anesthesia.
- •Hemodynamically stable patients with all routine investigations within normal limits .
- •Patients who are not on any cardiac related drugs.
- •Availability of written informed consent from concerned patient.
Exclusion Criteria
- •Patients not willing to get enrolled in this study.
- •Patients with ASA physical status III or more.
- •Patients below 18 years and above 65 years of age.
- •Patients posted for emergency procedures.
- •Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc.
- •Patients with bleeding or coagulation disorders.
- •Patients with known allergies to the study drugs.
Outcomes
Primary Outcomes
To compare the analgesic efficacy of 0.2% ropivacaine versus 0.2% ropivacaine with dexmedetomidine in ultrasound guided interscalene brachial plexus block in patients undergoing shoulder surgeries
Time Frame: After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time to rescue analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and at the end of surgery.
Secondary Outcomes
- To compare postoperative analgesia between the two groups using pain scores & requirement of rescue analgesia(Duration of analgesia will be assessed postoperatively once the effect of block wears off & time to rescue analgesia will be assessed at 2 hours after surgery & then hourly up to 24 hours postoperatively)
Investigators
Soumya Rayala
DR.D.Y.PATIL MEDICAL COLLEGE,PUNE,PIMPRI