Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries

NCT ID: NCT04981951

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-08-31

Brief Summary

In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.

Detailed Description

Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.

Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).

On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.

Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.

Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.

Conditions

Supraclavicular Brachial Plexus Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Dexmedetomidine and Bupivacaine

Patients will be given Dexemtomidine ( the intervention) added to the Bupivacaine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Highly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.

Bupivacaine alone

patients will be given Bupivacaine alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexmedetomidine

Highly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.

Intervention Type: DRUG

Other Intervention Names

non

Eligibility Criteria

Inclusion Criteria

• Aged between 18-75 years.
• Classified as grades 1 or 2 by the American Society of Anesthesiology Classification of .physical status.
• Willing and able to sign a consent form.

Exclusion Criteria

• Patients under the following conditions will be excluded: Known hypersensitivity to Bupivacaine, Dexmedetomidine, and local anesthetics.
• Uncontrolled diabetes mellitus.
• Peripheral neuropathy.
• SevereCoagulopathy.
• Infection at the site of block.
• Pregnancy.
• Cardiac arrhythmias.
• Prescription of beta blockers.
• Psychological disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zaher Nazzal

OTHER

Sponsor Role: lead

Responsible Party

Zaher Nazzal

Head of Research Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zaher Nazzal, MD

Role: PRINCIPAL_INVESTIGATOR

An-Najah National University

Wael Sadaqa, MD

Role: STUDY_DIRECTOR

An-Najah National University

Locations

Zaher Nazzal

Nablus, Wes-Bank, Palestinian Territories

Site Status: RECRUITING

Countries

Palestinian Territories

Central Contacts

Zaher Nazzal, MD

Role: CONTACT

znazzal@najah.edu

(+970) 9 2345113

Facility Contacts

Wael Sadaqa, MD

Role: primary

w.sadaqa@najah.edu

+970 599 782 246

Zaher Nazzal, MD

Role: backup

znazzal@najah.edu

+970 599 545 421

Other Identifiers

F.Med.25th August/2020/10

Identifier Type: -

Identifier Source: org_study_id