Peripheral Nerve BlockNCT07151443
Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block
A study testing Conventional approach to infraclavicular block and Retroclavicular approach to the infraclavicular block in people with Peripheral Nerve Block and Pain Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Forearm and hand surgeries are among the most frequently performed surgical interventions both in trauma patients and electively.In these procedures, alternative anesthesia methods such as general anesthesia, regional intravenous anesthesia, regional peripheral nerve blocks and local anesthesia are available. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Nerve Block, Pain Management, Forearm Surgery
- What is being tested?
- Conventional approach to infraclavicular block and Retroclavicular approach to the infraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 25 Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-80 years of age
- Those with ASA score II-III
- Those with a body mass index (BMI) >30
- Patients who are suitable for forearm and hand surgery under regional anesthesia in the operating room
Who cannot join
- Patients who cannot perceive and evaluate pain
- Patients who want to have surgery under general anesthesia
- Patients in whom regional anesthesia is contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
İbrahim Topcu, MD, 00905437860316, ibrahimtpc78@gmail.com
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
About this study
Official title: Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block in Obese Patients
Forearm and hand surgeries are among the most frequently performed surgical interventions both in trauma patients and electively.In these procedures, alternative anesthesia methods such as general anesthesia, regional intravenous anesthesia, regional peripheral nerve blocks and local anesthesia are available.
Peripheral nerve blockade can be used for anesthesia and analgesia.This method allows patients to undergo surgery without general anesthesia and increases patient satisfaction by providing effective analgesia in the postoperative period.
The aim of this study was to compare the conventional and retroclavicular approaches to infraclavicular block in patients undergoing forearm and hand surgery.
- Being tested
- Conventional approach to infraclavicular block, Retroclavicular approach to the infraclavicular block
- Keywords
- Infraclavicular Block, Obesity, Upper Extremity, Hand surgery, Forearm surgery
- Medical subject headings
- Agnosia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional approach to infraclavicular blockProcedure or surgery
Conventional approach to infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance.
Retroclavicular approach to the infraclavicular blockProcedure or surgery
Retroclavicular approach to the infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional approach to infraclavicular block | Active comparator | After the patients are monitored and placed in the supine position, after appropriate field sterilization, Conventional approach to infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance. Receives: Procedure: Conventional approach to infraclavicular block |
| Retroclavicular approach to the infraclavicular block | Active comparator | After the patients are monitored and placed in the supine position, after appropriate field sterilization, Retroclavicular approach to the infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance. Receives: Procedure: Retroclavicular approach to the infraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Performance Time
Total block performance time (from skin puncture to needle removal) will be recorded
Measured: During regional anesthesia
Secondary outcomes (2)
Pain Score
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest and when coughing. Pain assessment will be made at 0, 1, 6, 12, 18, and 24 hours after surgery.
Measured: Up to 24 hours
Patient Satisfaction
Quality of recovery-15 (QoR-15) score was used as the satisfaction score. The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Sep 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve BlockStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İbrahim Topcu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151443
- Sponsor's protocol ID
- AEŞH-EK-2025-006
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2025
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Retroclavicular Approaches for Ultrasound-guided Infraclavicular Brachial Plexus Block in Obese Patients
- ClinicalTrials.gov ID
- NCT07151443
- Acronym / sponsor ID
- AEŞH-EK-2025-006
- Keywords
- Infraclavicular Block, Obesity, Upper Extremity, Hand surgery, Forearm surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 3 Sep 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.
Forearm and hand surgeries are among the most frequently performed surgical interventions both in trauma patients and electively.In these procedures, alternative anesthesia methods such as general anesthesia, regional intravenous anesthesia, regional peripheral nerve blocks and local anesthesia are available.
Peripheral nerve blockade can be used for anesthesia and analgesia.This method allows patients to undergo surgery without general anesthesia and increases patient satisfaction by providing effective analgesia in the postoperative period.
The aim of this study was to compare the conventional and retroclavicular approaches to infraclavicular block in patients undergoing forearm and hand surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional approach to infraclavicular block | Active comparator | Procedure: Conventional approach to infraclavicular blockAfter the patients are monitored and placed in the supine position, after appropriate field sterilization, Conventional approach to infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance. |
| Retroclavicular approach to the infraclavicular block | Active comparator | Procedure: Retroclavicular approach to the infraclavicular blockAfter the patients are monitored and placed in the supine position, after appropriate field sterilization, Retroclavicular approach to the infraclavicular block will be performed on the patients using 25 ml of local anesthetic solution (20 ml 0.5% bupivacaine + 5 ml 2% lidocaine) under ultrasound guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18-80 years of age
- Those with ASA score II-III
- Those with a body mass index (BMI) >30
- Patients who are suitable for forearm and hand surgery under regional anesthesia in the operating room
Key exclusion criteria (3 listed)
- Patients who cannot perceive and evaluate pain
- Patients who want to have surgery under general anesthesia
- Patients in whom regional anesthesia is contraindicated
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 |
|---|---|---|
| Conventional approach to infraclavicular blockConventional approach to infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance. | Procedure or surgery | Conventional approach to infraclavicular block |
| Retroclavicular approach to the infraclavicular blockRetroclavicular approach to the infraclavicular block will be performed on the patients using 20 ml of 0.5% bupivacaine 5ml of %2 lidocaine under ultrasound guidance. | Procedure or surgery | Retroclavicular approach to the infraclavicular block |
Primary outcome
Block Performance Time
Time frame: During regional anesthesia
Total block performance time (from skin puncture to needle removal) will be recorded
2 secondary outcomes
Pain Score
Time frame: Up to 24 hours
Patient Satisfaction
Time frame: 1 day
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 15 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional approach to infraclavicular block and Retroclavicular approach to the infraclavicular block in people with Peripheral Nerve Block and Pain Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 15 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 Turkey (Türkiye). 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?
Contact Ibrahim Topcu, MD (+905437860316, ibrahimtpc78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block Performance Time (time frame: During regional anesthesia). 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 15 Dec 2025.