Clinical trial NCT04981951: Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries
Official title: Dexmedetomidine as an Adjuvant to Local Anesthesia in Supraclavicular Plexus Block, A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supraclavicular Brachial Plexus Block
Keywords: Dexmedetomidine
Randomized Controlled Trial.
Supraclavicular Plexus Block
bupivacaine
Palestine
Lead sponsor: An-Najah National University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The onset of anaesthesia in supraclavicular plexus block
timeFrame: "up to 9 hours"
measure: The duration of anesthesia in supraclavicular plexus block
timeFrame: "up to 9 hours"
Secondary outcomes:
measure: Intraoperative heart rate
timeFrame: "1 hour"
measure: Intraoperative blood pressure as mm Hg
timeFrame: "1 hour"
measure: Intraoperative somnolence
timeFrame: "1 hour"
measure: Post-operative heart rate
timeFrame: "up to 6 hours"
measure: Post-operative blood pressure
timeFrame: "up to 6 hours"
measure: Post-operative somnolence
timeFrame: "up to 6 hours"
measure: Number of Participants With Postoperative nausea and vomiting.
timeFrame: "up to 6 hours"
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: Zaher Nazzal
state: Wes-Bank
Study officials:
affiliation: An-Najah National University
name: Zaher Nazzal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: An-Najah National University
name: Wael Sadaqa, MD
role: STUDY_DIRECTOR
References: