Supraclavicular Brachial Plexus BlockNCT07012616
Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation
A study testing Supraclavicular brachial plexus block in people with Supraclavicular Brachial Plexus Block and Opioid Sparing, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Supraclavicular Brachial Plexus Block, Opioid Sparing, Pediatric
- What is being tested?
- Supraclavicular brachial plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2025to 15 Jan 2026
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 6 to 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I- III.
- Undergoing arteriovenous fistula creation under general anesthesia.
Who cannot join
- Allergy to local anesthetics.
- Infection at the site of block.
- Local infection.
- Coagulation disorder.
- Previously failed or revision of blocked arteriovenous fistula.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation: A Randomized Controlled Trial
This study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation.
Read the detailed description
The global incidence of end-stage renal failure (ESRF) is increasing. The preferred procedure for patients with ESRF undergoing maintenance Haemodialysis (HD) is the placement of an arteriovenous fistula (AVF).
In patients with ESRF, brachial plexus block (BPB) is frequently employed to administer anesthesia for the establishment or modification of AVF. This technique offers pain relief, sympathetic blockade, ideal surgical conditions, and a sufficient duration of postoperative block, preventing arterial spasms and graft thrombosis
- Being tested
- Supraclavicular brachial plexus block
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular brachial plexus blockOther
Patients will receive an ultrasound-guided supraclavicular brachial plexus block.
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular brachial plexus block group | Experimental | Patients will receive an ultrasound-guided supraclavicular brachial plexus block. Receives: Other: Supraclavicular brachial plexus block |
| Control group | No intervention | Patients will not receive supraclavicular brachial plexus block as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fentanyl consumption
Measured: Intraoperatively
Secondary outcomes (5)
Total opioid consumption
Rescue analgesia of 0.5 µg/kg fentanyl will be given if the Wong-Baker score is 4 more.
Measured: 24 hours postoperatively
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to the first dose of fentanyl administrated) will be assessed.
Measured: 24 hours postoperatively
Degree of pain
Degree of pain will be assessed using Wong-Baker score (0 to 10), 0= no hurt and 10= hurts worst. Wong-Baker score will be assessed at post-anesthesia care unit (PACU), 4, 6, 8, 12, 18 and 24 h postoperatively.
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, PONV, respiratory depression, or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jun 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012616
- Sponsor's protocol ID
- 36264PR1208/5/25
- Status last verified
- Jan 2026
- First submitted
- 31 May 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraclavicular Brachial Plexus Block as Opioid Sparing Technique in Pediatrics Undergoing Arteriovenous Fistula Creation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07012616
- Acronym / sponsor ID
- 36264PR1208/5/25
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 10 Jun 2025 (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.
This study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation.
Detailed description
The global incidence of end-stage renal failure (ESRF) is increasing. The preferred procedure for patients with ESRF undergoing maintenance Haemodialysis (HD) is the placement of an arteriovenous fistula (AVF).
In patients with ESRF, brachial plexus block (BPB) is frequently employed to administer anesthesia for the establishment or modification of AVF. This technique offers pain relief, sympathetic blockade, ideal surgical conditions, and a sufficient duration of postoperative block, preventing arterial spasms and graft thrombosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular brachial plexus block group | Experimental | Other: Supraclavicular brachial plexus blockPatients will receive an ultrasound-guided supraclavicular brachial plexus block. |
| Control group | No intervention | –Patients will not receive supraclavicular brachial plexus block as a control group. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age from 6 to 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I- III.
- Undergoing arteriovenous fistula creation under general anesthesia.
Key exclusion criteria (5 listed)
- Allergy to local anesthetics.
- Infection at the site of block.
- Local infection.
- Coagulation disorder.
- Previously failed or revision of blocked arteriovenous fistula.
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 |
|---|---|---|
| Supraclavicular brachial plexus blockPatients will receive an ultrasound-guided supraclavicular brachial plexus block. | Other | Supraclavicular brachial plexus block group |
Primary outcome
Intraoperative fentanyl consumption
Time frame: Intraoperatively
5 secondary outcomes
Total opioid consumption
Time frame: 24 hours postoperatively
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular brachial plexus block in people with Supraclavicular Brachial Plexus Block and Opioid Sparing, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jan 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative fentanyl consumption (time frame: Intraoperatively). 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 29 Jan 2026.