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

NCT ID: NCT06020781

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-03-11

Brief Summary

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.

Detailed 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

Conditions

Dexmedetomidine; Bupivacaine; Supraclavicular Brachial Plexus Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine and Dexmedetomidine

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

Group Type: EXPERIMENTAL

bupivacaine and dexmedetomidine.

Intervention Type: DRUG

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

20 ml Bupivacaine without additives

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

Group Type: ACTIVE_COMPARATOR

bupivacaine only

Intervention Type: DRUG

patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives

30 ml bupivacaine without additives

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

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

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

Interventions

bupivacaine and dexmedetomidine.

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

Intervention Type: DRUG

bupivacaine only

patient will receive Ultrasound -guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives

Intervention Type: DRUG

bupivacaine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Gamal Hendawy Shams

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-51

Identifier Type: -

Identifier Source: org_study_id