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Clinical trial

Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

ID
Name
NepalMCTH
Description
Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-07-30
Trial end
2023-07-30
Status
Recruiting
Treatment
ropivacaine, lidocaine with adrenaline
Group R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml
Arms:
Group R
Dexmedetomidine, ropivacaine, lidocaine with adrenaline
Dexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD
Arms:
Group RD
Size
40
Primary endpoint
Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine
5 months
Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
5 months
Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
5months
Eligibility criteria
Inclusion Criteria: * ASA physical status I and II patients, weight 45 to 74 kg * Elective upper limb surgery under brachial plexus block Exclusion Criteria: * known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine * Pregnant or lactating mothers * Hepatic, renal or cardiopulmonary abnormalities * Long term analgesic therapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-03-14

1 organization

2 products

3 indications

Organization
Nepal Medical College and Teaching Hospital
Product
Ropivacaine
Indication
Local Anesthetic Adjuvants
Indication
Fracture of upper extremity
Indication
Brachial Plexus Block
Product
Dexmedetomidine, Ropivacaine, Lidocaine with Adrenaline