Effect of patient controlled continuous infraclavicular block on early functional rehabilitation following surgeries for fractures around the elbow
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PGIMER
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mayo Elbow Performance Score
Study Overview
Brief Summary
Thisprospective, randomised clinical trial will be conducted in the department ofAnaesthesia and Intensive Care, PGIMER, Chandigarh with the aim ofinvestigating the effect of analgesia via patient controlled continuousinfraclavicular brachial plexus block technique, on early functionalrehabilitation after surgery for fractures around elbow. Patients will be allocated to one of the two groups of 20 patients each: Group Ipatients (n=20) will receive intravenous PCA in the postoperative period, usingpatient controlled bolus of 1mg Morphine intravenously with a lockout intervalof 15 minutes.Group IIpatients (n=20) will receive continuousinfraclavicular brachial plexus block using 0.2% Ropivacaine at a basal rate of5 ml / hr, with a patient controlled bolus of 3ml and a lockout interval of 30minutes. All patients will be assessed after3 weeks and 3 months following discharge. MEPS score will be assessed duringthese sessions by an assessor who is blinded to the group allocations.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients scheduled to undergo open reduction, internal fixation surgery for fractures around the elbow, under general anaesthesia will be enrolled in the study.
Exclusion Criteria
- •â–Local infection at the block site â–Brachial plexus injury â–Coagulopathy â–Sepsis â–Obesity (BMI>30) â–Allergy to local anesthetics / opioids â–Uncontrolled hypertension or ischemic heart disease â–Renal or hepatic dysfunction â–Bronchopulmonary disorders â–Pre-existing neurological deficit â–Prior surgery in the infraclavicular area â–Psychiatric illness â–Inability to cooperate or understand the study protocol.
- •â–Patients who fail to understand the scoring systems used in the study â–Refusal to give consent for the study.
Outcomes
Primary Outcomes
Mayo Elbow Performance Score
Time Frame: 3 weeks following discharge
Secondary Outcomes
- 1.Mayo Elbow Performance Score at 3 months following discharge from the hospital(2. Numeric rating scale (NRS) score 4 hourly for 72 hours)