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

Supraclavicular Brachial Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981951
• Other study ID #: F.Med.25th August/2020/10
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: An-Najah National University
• Contact: Zaher Nazzal, MD
• Phone: (+970) 9 2345113
• Email: znazzal[@]najah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Supraclavicular Brachial Plexus Block

Intervention

Drug:
• Dexmedetomidine
Highly selective a2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.

Locations

Country	Name	City	State
Palestinian Territory, occupied	Zaher Nazzal	Nablus	Wes-Bank

Sponsors (1)

Lead Sponsor	Collaborator
Zaher Nazzal

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"
Primary	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	Intraoperative heart rate	Heart rate per min is assessed intraoperatively	"1 hour"
Secondary	Intraoperative blood pressure as mm Hg	Blood pressure assessed by a non-invasive monitor	"1 hour"
Secondary	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"
Secondary	Post-operative heart rate	Heart rate per min is assessed postoperatively	"up to 6 hours"
Secondary	Post-operative blood pressure	Blood pressure assessed by a non-invasive monitor	"up to 6 hours"
Secondary	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"
Secondary	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"