Clinical trial

Infraclavicular Brachial Plexus Block Using Bupivacaine Alone or in Combination With Dexmedetomidine and Dexamethasone for Hand and Forearm Surgeries, A Randomized, Controlled Trial

Name
Dex Dex in infraclavicular
Description
Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.
Trial arms
Trial start
2024-05-01
Estimated PCD
2024-08-30
Trial end
2024-09-30
Status
Not yet recruiting
Treatment
Bupivacaine injection
Group one will receive infraclavicular block using bupivacaine
Arms:
Bupivacaine
Bupivacaine+ Dexamethasone+ Dexmedetomidine
Group two will receive infraclavicular block using dexamethasone and dexmedetomidine added to the bupivacaine
Arms:
Bupivacaine+ Dexamethasone+ Dexmedetomidine
Size
40
Primary endpoint
Onset of sensory block
Immediately after the performance of the infraclavicular block
Eligibility criteria
Inclusion Criteria: * Age 18-65 years * American Society of Anesthesiologists physical status I-II * Body mass index between 18 and 35 kg/ m2 * scheduled for forearm and hand surgeries Exclusion Criteria: * Inability to consent to the study * Coagulopathy * Sepsis * Decompensated chronic hepatic or renal illnesses * Allergy to any of the used drugs * Pre-existing musculocutaneous/median/radial/ ulnar neuropathy * Prior surgery in the infraclavicular fossa
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-04-10

1 organization

2 products

1 indication