Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

Kafrelsheikh University

Status: Completed

Conditions: Supraclavicular Brachial Plexus Block; Bupivacaine; Dexmedetomidine

Treatments: Drug: bupivacaine only; Drug: bupivacaine and dexmedetomidine.; Drug: bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06020781

KFSIRB200-51

Details and patient eligibility

About

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.

Full description

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Bupivacaine and Dexmedetomidine

Experimental group

Description:

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.

Treatment:

Drug: bupivacaine and dexmedetomidine.

20 ml Bupivacaine without additives

Active Comparator group

Description:

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.

Treatment:

Drug: bupivacaine only

30 ml bupivacaine without additives

Active Comparator group

Description:

Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.

Treatment:

Drug: bupivacaine