A comparative randomized double blind study of two different doses of Dexmedetomidine combined with Levobupivacaine in supraclavicular brachial plexus block under peripheral nerve stimulator guidance
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To compare the duration of analgesia between the two groups
Study Overview
Brief Summary
A study titled A comparative randomized double blind study of two different doses of Dexmedetomidine combined with Levobupivacaine in supraclavicular brachial plexus block under peripheral nerve stimulator guidance was carried put in GMC KADAPA during the period from January 2023 to December 2023
This study included 100 patients randomly divided in to two groups of 50 patients in each group In group LD50 patients received 24ml of 0.5% Levobupivacaine combined with 50mcg of Dexmedetomidine diluted in 1ml of normal saline (total of 25ml) in supraclavicular brachial plexus block under peripheral nerve stimulator guidance where as in the other group Group LD100 patients received 24ml of 0.5% Levobupivacaine combined with 100mcg of Dexmedetomidine diluted in 1ml of normal saline (total of 25ml) in supraclavicular brachial plexus block under peripheral nerve stimulator guidance
Parameters such as onset of sensory and motor blockade duration of sensory and motor blockade duration of analgesia hemodynamics number of rescue analgesics in 24 hours sedation and adverse effects were noted
In this study significantly longer duration of analgesia was observed in Group LD100 when compared to Group LD50 A statistically significant faster onset and prolonged duration of sensorimotor blockade was observed in Group LD100 compared to LD50
Hemodynamic parameters including SBP DBP and MAP were found statistically significant from 5 minutes to 6 hours post administration of block in Group LD100 compared to group LD50 The number of rescue analgesics required in 24 hours was significantly higher in group LD50 when compared to group LD100
Incidence of adverse events like Bradycardia (HR<60bpm) Sedation score(>3) was significantly higher in group LD100 and they were manageable The incidence of hypotension (MAP<65mmHg) was comparable between two groups
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
- •Age between 18 to 60 years ASA physical status I and II Patients scheduled for elective open reduction and internal fixation of fracture both bones forearm after obtaining written/informed consent from the patients.
Exclusion Criteria
- •Known allergy to local anaesthetic agents(known hypersensitivity to study drugs) Traumatic nerve injury History of respiratory disorders History of neuromuscular diseases History of cardiovascular diseases Bleeding disorders or patients on anticoagulant therapy Hepatic or renal failure Pregnant and lactating women Drug abusers and psychiatry patients.
Outcomes
Primary Outcomes
To compare the duration of analgesia between the two groups
Time Frame: every 30 minutes up to 24 hours till block is completely worn off
Secondary Outcomes
- To compare the onset of sensory and motor blockade between the two groups(To compare the duration of sensory and motor blockade between the two groups)
Investigators
Sunkesula Abdullah
Government medical college kadapa