NCT07151443

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

February 13, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

February 13, 2025

Last Update Submit

December 8, 2025

Conditions

Peripheral Nerve BlockPain ManagementForearm SurgeryHand SurgeryUpper Extremity

Keywords

Infraclavicular BlockObesityUpper ExtremityHand surgeryForearm surgery

Outcome Measures

Primary Outcomes (1)

  • Block Performance Time

    Total block performance time (from skin puncture to needle removal) will be recorded

    During regional anesthesia

Secondary Outcomes (2)

  • Pain Score

    Up to 24 hours

  • Patient Satisfaction

    1 day

Study Arms (2)

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.

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.

Procedure: Retroclavicular approach to the infraclavicular block

Interventions

Conventional approach to infraclavicular blockPROCEDURE

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.

Conventional approach to infraclavicular block
Retroclavicular approach to the infraclavicular blockPROCEDURE

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.

Retroclavicular approach to the infraclavicular block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who cannot perceive and evaluate pain
  • Patients who want to have surgery under general anesthesia
  • Patients in whom regional anesthesia is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AgnosiaObesity

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Central Study Contacts

Ibrahim Topcu, MD

CONTACT

+905437860316ibrahimtpc78@gmail.com

Musa Zengin, Associate Professor

CONTACT

+905307716235musazengin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2025

First Posted

September 3, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations

TU(1)