Comparison of Levobupivacaine and Ropivacaine on Diaphragmatic function in patients undergoing Forearm surgeries under ultrasound guided Supraclavicular Brachial Plexus Block - a randomised control trial
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 182
- Locations
- 1
Study Overview
Brief Summary
Ropivacaine and Levobupivacaine are two commonly used local anaesthetics in supraclavicular block for forearm surgeries. Various complications can occur with supraclavicular block like hemidiaphragmatic paralysis (HDP) which is usually asymptomatic in healthy individuals but severe complications exists in patients with respiratory compromise. Various other complications can also be associated with supraclaviclavicular block.
The study compares the incidence of HDP in patients who will be given Levobupivacaine vs ropivacaine under ultrasound guidance supraclavicular brachial plexus block in forearm surgeries.
A total sample size of 182 patients will be selected based upon the inclusion and exclusion criteria and will be randomly divided into 2 groups with each group consisting of 91 patients.
Baseline assessment will be done followed by post block assessment for diaphragmatic paralysis at 15 mins, 30 mins and 2 hours and patients shall be assessed whether they are asymptomatic or symptomatic.
NRS score of the patients will be taken post operatively at 6 hours, 12 hours and 24 hours to assess for pain. Rescue analgesia shall be provided to the patient as needed.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 64.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA Grade 1 and 2 2) Forearm Surgeries.
Exclusion Criteria
- •Patient refusal 2) Local infection 3) Bleeding disorders 4) Coagulopathies 5) Allergic to local anesthetic agent 6) Patients with neuromuscular disorders and weakness and hemidiaphragmatic dysfunction 7) Patients with pre-existing cardiac and lung pathologies 8) Pregnancy.
Investigators
Vemulapalli Meghana
Nizam’s Institute of Medical Sciences