Comparative study to evaluate the effect of dexmeditomedine as adjuvant to 0.5% bupivacaine with 0.5% plain bupivcaine under USG guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anaesthesia.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The duration of post-operative analgesia with dexmeditomedine as adjuvant to 0.5% bupivacaine will be significantly more as compared to 0.5% plain bupivcaine.
Study Overview
Brief Summary
This study protocol aims to evaluate the effect of dexmeditomedine as adjuvant to 0.5% bupivacaine and 0.5% plain bupivacaine under usg guided interscalene brachial plexus block (ISBPB) for patient undergoing shoulder arthroscopy under general anesthesia. The primary objective is to assess the postoperative analgesia with dexmeditomedine as adjuvant to 0.5% bupivacaine with 0.5% plain bupivacaine under usg guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anesthesia. Secondary objectives include to evaluate the Intraoperative Hemodynamic stability and Side effects (if any). The study will be conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital in Sawangi, Wardha, over a 2-year period. The study design is Prospective Randomized Interventional Study, and the source of data will be patients aged 18 to 65 years undergoing under usg guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anesthesia. A total of 60 patients will be included, with 30 in each group. Patients meeting the inclusion criteria will be alternative randomly allocated into one of those two groups (Group B & Group BD of patients in each group and both groups will receive equal volume of drug (0.5% Bupivacaine 20ml + 0.2 ml adjuvant, so total of 20.2 ml). Outcome measures include the postoperative analesgia, Intraoperative Hemodynamic stability and Side effects as well as pain scores assessed using a visual analogue scale. Postoperative pain was measured for first 6 hours using the visual analog scale (VAS). Data will be analyzed using appropriate statistical tests, and ethical considerations will be followed throughout the study. The results of this study are expected to provide insights into the potential benefits of dexmedetomidine as an adjuvant in peripheral nerve blocks for shoulder arthroscopy, contributing to enhanced postoperative pain management strategies and patient outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with ASA physical status I & II will be considered for inclusion.
- •2.Patients who are scheduled to undergo elective shoulder arthroscopy will be eligible.
- •3.Individuals aged between 18 and 65 years old will be included in the study.
- •4.Patients who express a willingness to actively participate in the study will be considered for enrollment.
Exclusion Criteria
- •1.Patients who refuse to participate will be excluded from the study.
- •2.Individuals with known allergies to local anesthetics and opioids will not be included.
- •3.Patients with a local infection at the site of the intended block will be excluded.
- •4.Pregnant women will not be eligible for participation.
- •5.Individuals with severe cardiopulmonary diseases will be excluded from the study.
- •6.Patients with neurological deficits in the arm selected for surgery will not be considered.
- •7.Individuals with bleeding disorders or those currently on anticoagulant medications will be excluded from participation.
Outcomes
Primary Outcomes
The duration of post-operative analgesia with dexmeditomedine as adjuvant to 0.5% bupivacaine will be significantly more as compared to 0.5% plain bupivcaine.
Time Frame: Assessments will be done at 30 min, 1 hour, 2, 3,4,5 and 6 hours. Study will be conducted over a period of 2 years.
Secondary Outcomes
- Intraoperative Hemodynamic stability and Side Effects
Investigators
Dr Meenal Rajput
Datta Meghe Institute of Higher Education and Research