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

Dexmedetomidine as an Adjuvant to Local Anesthesia in Supraclavicular Plexus Block, A Randomized Control Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Supraclavicular Brachial Plexus Block
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zaher Nazzal, MD; Phone Number: (+970) 9 2345113; Email: znazzal@najah.edu

Study Locations

• Palestinian Territory, occupied
  • Wes-Bank
    • Nablus, Wes-Bank, Palestinian Territory, occupied, 7704
      • Recruiting
      • Zaher Nazzal
      • Contact: Wael Sadaqa, MD; Phone Number: +970 599 782 246; Email: w.sadaqa@najah.edu
      • Contact: Zaher Nazzal, MD; Phone Number: +970 599 545 421; Email: znazzal@najah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine and Bupivacaine; Patients will be given Dexemtomidine ( the intervention) added to the Bupivacaine	Drug: Dexmedetomidine; Highly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.; Other Names: non
No Intervention: Bupivacaine alone; patients will be given Bupivacaine alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative heart rate	Heart rate per min is assessed intraoperatively	"1 hour"
Intraoperative blood pressure as mm Hg	Blood pressure assessed by a non-invasive monitor	"1 hour"
Intraoperative somnolence	Somnolence assessed using Ramsay Sedation Scale. It grades somnolence on a scale of 1-6: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response	"1 hour"
Post-operative heart rate	Heart rate per min is assessed postoperatively	"up to 6 hours"
Post-operative blood pressure	Blood pressure assessed by a non-invasive monitor	"up to 6 hours"
Post-operative somnolence	Somnolence assessed using Ramsay Sedation Scale. It grades somnolence on a scale of 1-6: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response	"up to 6 hours"
Number of Participants With Postoperative nausea and vomiting.	Vomiting assessed by mentoring the patients actively. Nausea assessed by asking the patients directly.	"up to 6 hours"

Collaborators and Investigators

• Sponsor: Zaher Nazzal
• Investigators: Principal Investigator: Zaher Nazzal, MD, An-Najah National University; Study Director: Wael Sadaqa, MD, An-Najah National University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; bupivacaine; Randomized Controlled Trial.; Supraclavicular Plexus Block; Palestine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: F.Med.25th August/2020/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No