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

NCT04981951 | Unknown

• 1 other identifier: F.Med.25th August/2020/10
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraclavicular Brachial Plexus Block

Keywords

Dexmedetomidine; Randomized Controlled Trial.; Supraclavicular Plexus Block; bupivacaine; Palestine

Outcome Measures

Primary Outcomes (2)

• The onset of anaesthesia in supraclavicular plexus block

  Sensory block assessed by pinprick test with a blunt 25-G hypodermic needle. Grade 0: sharp pin sensation felt, grade 1: analgesia, dull sensation felt, grade 2: anesthesia, no sensation felt the onset of sensory block is the interval between the end of total local anesthetic administration and sensory block grade 1

  "up to 9 hours"

• The duration of anesthesia in supraclavicular plexus block

  The motor blockade assessed using the Modified Bromage scale (MBS). Grade 0: able to raise the extended arm to 90 degrees for 2 seconds; grade 1: able to bend the elbow and move the fingers but not the extended arm; grade 2: unable to flex the elbow but able to move the fingers; grade 3: unable to move the arm, elbow, and fingers. The onset of the motor blockade is the interval from injection of the local anesthetic to motor analysis equivalent to Bromage score 2

  "up to 9 hours"

Secondary Outcomes (7)

• Intraoperative heart rate

  "1 hour"

• Intraoperative blood pressure as mm Hg

  "1 hour"

• Intraoperative somnolence

  "1 hour"

• Post-operative heart rate

  "up to 6 hours"

• Post-operative blood pressure

  "up to 6 hours"

Study Arms (2)

Dexmedetomidine and Bupivacaine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Bupivacaine alone

NO INTERVENTION

patients will be given Bupivacaine alone

Interventions

Dexmedetomidine DRUG

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

Also known as: non

Dexmedetomidine and Bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zaher Nazzal: lead

Study Sites (1)

Zaher Nazzal

Nablus, Wes-Bank, 7704, Palestinian Territories

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zaher Nazzal, MD

  An-Najah National University

  PRINCIPAL INVESTIGATOR

• Wael Sadaqa, MD

  An-Najah National University

  STUDY DIRECTOR

Central Study Contacts

Zaher Nazzal, MD

CONTACT

(+970) 9 2345113; znazzal@najah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Unit

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: July 29, 2021
• Study Start: October 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

PA (1)