Supraclavicular Brachial Plexus BlockNCT04981951
Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries
A study testing Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Zaher Nazzal at 1 site in Palestinian Territories.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraclavicular Brachial Plexus Block
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Oct 2020to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Cardiac arrhythmias.
- Prescription of beta blockers.
- Psychological disorders.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site, 1 recruiting
- Recruiting
Zaher Nazzal
Nablus, Wes-Bank, 7704
Wael Sadaqa, MD, +970 599 782 246, w.sadaqa@najah.edu
Zaher Nazzal, MD, +970 599 545 421, znazzal@najah.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Randomized Controlled Trial., Supraclavicular Plexus Block, bupivacaine, Palestine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called non
Highly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine and Bupivacaine | Experimental | Patients will be given Dexemtomidine ( the intervention) added to the Bupivacaine Receives: Drug: Dexmedetomidine |
| Bupivacaine alone | No intervention | patients will be given Bupivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "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
Measured: "up to 9 hours"
Secondary outcomes (7)
Intraoperative heart rate
Heart rate per min is assessed intraoperatively
Measured: "1 hour"
Intraoperative blood pressure as mm Hg
Blood pressure assessed by a non-invasive monitor
Measured: "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
Measured: "1 hour"
Post-operative heart rate
Heart rate per min is assessed postoperatively
Measured: "up to 6 hours"
Post-operative blood pressure
Blood pressure assessed by a non-invasive monitor
Measured: "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
Measured: "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.
Measured: "up to 6 hours"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Oct 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zaher Nazzal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zaher Nazzal, An-Najah National University
- Investigators
- Zaher Nazzal, MD, Principal investigator, An-Najah National UniversityWael Sadaqa, MD, Study director, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981951
- Sponsor's protocol ID
- F.Med.25th August/2020/10
- Status last verified
- Jul 2023
- First submitted
- 30 May 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Local Anesthesia in Supraclavicular Plexus Block, A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04981951
- Acronym / sponsor ID
- F.Med.25th August/2020/10
- Conditions
- Supraclavicular Brachial Plexus Block
- Keywords
- Dexmedetomidine, Randomized Controlled Trial., Supraclavicular Plexus Block, bupivacaine, Palestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zaher NazzalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine and Bupivacaine | Experimental | Drug: DexmedetomidinePatients will be given Dexemtomidine ( the intervention) added to the Bupivacaine |
| Bupivacaine alone | No intervention | –patients will be given Bupivacaine alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: nonHighly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties. | Drug | Dexmedetomidine and Bupivacaine |
Primary outcome
The onset of anaesthesia in supraclavicular plexus block
Time frame: "up to 9 hours"
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
The duration of anesthesia in supraclavicular plexus block
Time frame: "up to 9 hours"
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
7 secondary outcomes
Intraoperative heart rate
Time frame: "1 hour"
Intraoperative blood pressure as mm Hg
Time frame: "1 hour"
Intraoperative somnolence
Time frame: "1 hour"
Post-operative heart rate
Time frame: "up to 6 hours"
Post-operative blood pressure
Time frame: "up to 6 hours"
Post-operative somnolence
Time frame: "up to 6 hours"
Number of Participants With Postoperative nausea and vomiting.
Time frame: "up to 6 hours"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaher Nazzal, MD principal investigator
An-Najah National University
Wael Sadaqa, MD study director
An-Najah National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Supraclavicular Brachial Plexus Block, run by Zaher Nazzal at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaher Nazzal, MD ((+970) 9 2345113, znazzal@najah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The onset of anaesthesia in supraclavicular plexus block (time frame: "up to 9 hours"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.