Effect of intravenous dexmedetomidine infusion on femoro-sciatic nerve block in below knee surgeries: a randomized clinical trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- GOKULNATH THANGARAJ
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- to access the Motor and Sensory Block characteristics
Overview
Brief Summary
This study will be a randomized double blinded, prospective, comparative study, to be carried out in 52 patients of ASA I and II undergoing below knee surgery with combined femoral and sciatic nerve block (popliteal-sciatic approach).
The patients will be randomly divided into two groups of 26 each. Group B (n=26) will receive inj. 0.375% Ropivacaine (40ml) with 20ml of intravenous infusion of dexmedetomidine over 10minuets. Group A (n=30) will receive inj. 0.375% Ropivacaine (40ml) with intravenous infusion 20ml of Normal Saline over 10 minuets.
The onset and duration of sensory block and motor block, duration of analgesia or time to first rescue analgesic request (TFAR) and side effects will be assessed and recorded.
All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference drawn to evaluate and compare the two groups on sensory and motor block onset and duration .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of age group 18 to 60 years.
- •Patients of American Society of Anaesthesiologists (ASA) physical grade I or II.
Exclusion Criteria
- •Hypersensitivity to the amide group of local anaesthetic agents and dexmedetomidine.
- •Patients having hypertension/diabetes mellitus / neuropathy / peripheral nerve injury
- •Pregnancy and lactation
- •Patient on anticoagulants or bleeding disorder
- •Patients having problems in communication
- •Infection at the site of drug injection.
Outcomes
Primary Outcomes
to access the Motor and Sensory Block characteristics
Time Frame: Outcome will be assessed from the point of | administration of femoro-sciatic nerve block till 24hrs after the surgery. Data will be then | assessed at the end of two years.
Secondary Outcomes
No secondary outcomes reported
Investigators
GOKULNATH THANGARAJ
Regional Institute of Medical Sciences, Imphal, Manipur