Achievement of High-quality Analgesia in Elbow SurgeriesNCT07209995
Ultrasound Guided Retroclavicular Infraclavicular Versus Axillary Block as Regional Anesthesia in Obese Patients
A study testing retroclavicular infraclavicular brachial plexus block for and axillary block in people with Achievement of High-quality Analgesia in Elbow Surgeries, run by Zagazig University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following the ultrasound-guided retroclavicular infraclavicular approach and the axillary approach in obese patients. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Achievement of High-quality Analgesia in Elbow Surgeries
- What is being tested?
- retroclavicular infraclavicular brachial plexus block for and axillary block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients acceptance to share in the study.
- Patients with ASA physical status I-II.
- Obese patients (BMI 30-40 kg/m²) undergoing around and below elbow surgeries under regional anesthesia.
- Patients requiring a single injection infraclavicular retroclavicular brachial plexus block or axillary block for around and below elbow surgeries.
Who cannot join
- Patients with a history of allergic reactions or contraindications to local anesthetics.
- Patients with significant comorbidities (e.g., severe cardiovascular, neurological, or musculoskeletal disorders).
- Patients with a history of previous shoulder or clavicle surgery that may distort anatomy and affect the efficacy of the block.
- Pregnant or breastfeeding women.
- Patients with a history of systemic infections or skin infections in the area of the block.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound Guided Retroclavicular Infraclavicular Versus Axillary Block as Regional Anesthesia in Obese Patients Undergoing Around and Below Elbow Surgeries: A Randomized Clinical Study
The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following the ultrasound-guided retroclavicular infraclavicular approach and the axillary approach in obese patients.
- Being tested
- retroclavicular infraclavicular brachial plexus block for, axillary block
- Keywords
- retroclavicular infraclavicular approach the axillary block obese patients elbow surgeries.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroclavicular infraclavicular brachial plexus block forOther
The patient will be placed supine, head facing the contralateral side. A high- frequency 13-6 MHz linear array transducer probe will be placed medial to the coracoid process below and perpendicular to the clavicle to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will be inserted in the supraclavicular fossa, approximately one cm posteriorly to the clavicle, and advanced in plane parallel to the probe. After passing the initial blind zone of about 2 cm caused by the clavicle's acoustic shadow, the needle tip will be continuously seen, until it appears posterior to the axillary artery. A single injection of the local an esthetic will be performed without needle repositioning unless paresthesia is elicited
axillary blockOther
The axillary nerve block is performed from behind the patient with the patient seated. The axillary nerve will be identified within the quadrilateral space by placing high frequency linear probe parallel to the long axis of the humeral shaft. The nerve was identified next to the circumflex artery
| Study group | Role | What they receive |
|---|---|---|
| Group (R) | Active comparator | Patients will recieve retroclavicular infraclavicular brachial plexus block Receives: Other: retroclavicular infraclavicular brachial plexus block for |
| Group (A) | Active comparator | Patients will receive the axillary brachial plexus Receives: Other: axillary block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request in each group
Measured: 24 hours postoperative
Secondary outcomes (9)
Block assessment and definition of successful block
Measured: 30 minutes after the block
Imaging time
Measured: the time between probe application and insertion of the needle
Needle time
Measured: the time between insertion of the needle and complete injection of local anesthetic
-Procedure time
Measured: the summation of the imaging and needling times
Pain intensity
10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1 - 3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 - 6: Moderate pain (significantly interfering with ADLs, 7 - 10: Severe pain (disabling, unable to perform ADLs)]
Measured: basal, one, 2, 4, 8, 12, 16, 20 and 24 hours postoperative
Total analgesia need
Measured: the first postoperative 24 hours
Duration of the sensory block
Measured: first 24 hours postoperative
Duration of the motor block
Measured: first 24 hours postoperative
Incidence of block complications
hematoma formation or paresthesia or local anesthetic systemic toxicity.
Measured: first 24 h0urs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Oct 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achievement of High-quality Analgesia in Elbow SurgeriesStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- Howida A Kamal, MD, Study director, faculty of medicine,zagazig university Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209995
- Sponsor's protocol ID
- ZU-IRB#1680/23-Sep-2025
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Retroclavicular Infraclavicular Versus Axillary Block as Regional Anesthesia in Obese Patients Undergoing Around and Below Elbow Surgeries: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07209995
- Acronym / sponsor ID
- ZU-IRB#1680/23-Sep-2025
- Keywords
- retroclavicular infraclavicular approach the axillary block obese patients elbow surgeries.
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 7 Oct 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.
The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following the ultrasound-guided retroclavicular infraclavicular approach and the axillary approach in obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (R) | Active comparator | Other: retroclavicular infraclavicular brachial plexus block forPatients will recieve retroclavicular infraclavicular brachial plexus block |
| Group (A) | Active comparator | Other: axillary blockPatients will receive the axillary brachial plexus |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients acceptance to share in the study.
- Patients with ASA physical status I-II.
- Obese patients (BMI 30-40 kg/m²) undergoing around and below elbow surgeries under regional anesthesia.
- Patients requiring a single injection infraclavicular retroclavicular brachial plexus block or axillary block for around and below elbow surgeries.
Key exclusion criteria (5 listed)
- Patients with a history of allergic reactions or contraindications to local anesthetics.
- Patients with significant comorbidities (e.g., severe cardiovascular, neurological, or musculoskeletal disorders).
- Patients with a history of previous shoulder or clavicle surgery that may distort anatomy and affect the efficacy of the block.
- Pregnant or breastfeeding women.
- Patients with a history of systemic infections or skin infections in the area of the 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 |
|---|---|---|
| retroclavicular infraclavicular brachial plexus block forThe patient will be placed supine, head facing the contralateral side. A high- frequency 13-6 MHz linear array transducer probe will be placed medial to the coracoid process below and perpendicular to the clavicle to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will be inserted in the supraclavicular fossa, approximately one cm posteriorly to the clavicle, and advanced in plane parallel to the probe. After passing the initial blind zone of about 2 cm caused by the clavicle's acoustic shadow, the needle tip will be continuously seen, until it appears posterior to the axillary artery. A single injection of the local an esthetic will be performed without needle repositioning unless paresthesia is elicited | Other | Group (R) |
| axillary blockThe axillary nerve block is performed from behind the patient with the patient seated. The axillary nerve will be identified within the quadrilateral space by placing high frequency linear probe parallel to the long axis of the humeral shaft. The nerve was identified next to the circumflex artery | Other | Group (A) |
Primary outcome
Time to first analgesic request in each group
Time frame: 24 hours postoperative
9 secondary outcomes
Block assessment and definition of successful block
Time frame: 30 minutes after the block
Imaging time
Time frame: the time between probe application and insertion of the needle
Needle time
Time frame: the time between insertion of the needle and complete injection of local anesthetic
-Procedure time
Time frame: the summation of the imaging and needling times
Pain intensity
Time frame: basal, one, 2, 4, 8, 12, 16, 20 and 24 hours postoperative
Total analgesia need
Time frame: the first postoperative 24 hours
Duration of the sensory block
Time frame: first 24 hours postoperative
Duration of the motor block
Time frame: first 24 hours postoperative
Incidence of block complications
Time frame: first 24 h0urs postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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.
Howida A Kamal, MD study director
faculty of medicine,zagazig university Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retroclavicular infraclavicular brachial plexus block for and axillary block in people with Achievement of High-quality Analgesia in Elbow Surgeries, run by Zagazig 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: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to first analgesic request in each group (time frame: 24 hours postoperative). 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 16 Dec 2025.