Clinical trial
Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block
Name
KFSIRB200-51
Description
The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.
Trial arms
Trial start
2023-10-09
Estimated PCD
2024-03-11
Trial end
2024-03-11
Status
Completed
Treatment
bupivacaine and dexmedetomidine.
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
Arms:
Bupivacaine and Dexmedetomidine
bupivacaine only
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives
Arms:
20 ml Bupivacaine without additives
bupivacaine
patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
Arms:
30 ml bupivacaine without additives
Size
75
Primary endpoint
Success rate.
30 minutes after block performance
Eligibility criteria
Inclusion Criteria:
* American Society of Anesthesiologist (ASA) grade I or II patients
* both sexes
* scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .
Exclusion Criteria:
* with pre-existing peripheral neuropathy of upper limb.
* Bleeding disorders.
* Infection at injection site.
* Untreated pneumothorax.
* Patients on adrenoreceptor agonist or antagonist therapy.
* History of severe cardiac,.respiratory, hepatic, or renal disease.
* pregnancy and known hypersensitivity to the study drugs.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2024-04-02
1 organization
3 products
3 indications
Organization
Kafrelsheikh UniversityIndication
DexmedetomidineIndication
BupivacaineIndication
Supraclavicular Brachial Plexus BlockProduct
BupivacaineProduct
bupivacaine