Clinical trial
Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block
Name
146:4/2019
Description
Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.
Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind
Trial arms
Trial start
2019-04-21
Estimated PCD
2020-12-28
Trial end
2020-12-30
Status
Completed
Treatment
Supraclavicular Brachial Plexus Block with bupivacaine
drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Arms:
Control group
Other names:
C group
Supraclavicular Brachial Plexus Block with Ketamine
drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Arms:
Ketamine group
Other names:
K group
Supraclavicular Brachial Plexus Block with Dexmedetomidine
drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
Device: ultrasound-guided supraclavicular Brachial Plexus nerve block
Arms:
Dexmedetomidine group
Other names:
D group
Size
75
Primary endpoint
Evaluate duration of sensory block
24 hours after block
Eligibility criteria
Inclusion Criteria:
* American Physical Status I or II
* patients undergoing elective and emergency forearm and hand surgeries
Exclusion Criteria:
* Patient with bleeding disorders
* Damage or disease of the brachial plexus
* Uncontrolled diabetes mellitus
* Patients with neuromuscular diseases
* Patients with a local skin infection at the site of injection
* Patients with known hypersensitivity to studied 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
2023-08-01
1 organization
3 products
1 indication
Organization
Minia UniversityIndication
Supraclavicular Brachial Plexus Block