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

NCT06020781 | Completed

• 1 other identifier: KFSIRB200-51
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Bupivacaine; Supraclavicular Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Success rate.

  Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.

  30 minutes after block performance

Secondary Outcomes (5)

• Total pethidine consumption.

  24 hours postoperative.

• Pain score.

  24 hours postoperative.

• Mean arterial blood pressure

  From preoperatively till the end of surgery

• Heart rate

  From preoperatively till the end of surgery

• Postoperative side effects.

  24 hours postoperative

Study Arms (3)

Bupivacaine and Dexmedetomidine

EXPERIMENTAL

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

Drug: bupivacaine and dexmedetomidine.

20 ml Bupivacaine without additives

ACTIVE COMPARATOR

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

Drug: bupivacaine only

30 ml bupivacaine without additives

ACTIVE COMPARATOR

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

Drug: bupivacaine

Interventions

bupivacaine and dexmedetomidine. DRUG

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

Bupivacaine and Dexmedetomidine

bupivacaine only DRUG

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

20 ml Bupivacaine without additives

bupivacaine DRUG

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

30 ml bupivacaine without additives

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: October 9, 2023
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)