NCT07324681

Brief Summary

This randomized prospective study evaluates the effect of general anesthesia versus infraclavicular nerve block on perioperative serum irisin levels in adults undergoing forearm fracture surgery. Irisin levels will be measured preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively. The association between irisin changes and fracture healing will be explored as a secondary outcome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

December 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 24, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

irisininfraclavicular blockforearm fracture

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Irisin Levels

    Serum irisin levels (ng/dL) will be measured to evaluate the effect of anesthesia type on perioperative irisin response. Blood samples will be collected at three time points: preoperatively (baseline), 30 minutes postoperatively, and 24 hours postoperatively. Changes in irisin levels will be compared between the general anesthesia group and the infraclavicular block group.

    Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively

Secondary Outcomes (1)

  • Radiological Fracture Healing and Callus Formation

    Postoperative follow-up period (up to 6 months)

Study Arms (2)

General Anesthesia (GA) Group

ACTIVE COMPARATOR

Adult patients undergoing elective forearm fracture surgery under general anesthesia. Standard noninvasive monitoring will be used and perioperative hemodynamic variables and analgesic use will be recorded. Blood samples for serum irisin will be collected preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively.

Procedure: General Anesthesia (GA)

Infraclavicular Block (ICB) Group

EXPERIMENTAL

Adult patients undergoing elective forearm fracture surgery with an ultrasound-guided infraclavicular brachial plexus block performed approximately 1 hour before surgery under monitored conditions. Standard noninvasive monitoring will be used; perioperative hemodynamic variables and analgesic use will be recorded. Blood samples for serum irisin will be collected preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively.

Procedure: Infraclavicular Brachial Plexus Blocks

Interventions

General anesthesia administered according to institutional routine; anesthetic drugs and doses will be recorded.

General Anesthesia (GA) Group

Ultrasound-guided infraclavicular block performed preoperatively; details of technique, local anesthetic drugs and doses will be recorded.

Infraclavicular Block (ICB) Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 65 years
  • Scheduled for elective forearm fracture surgery
  • Planned to receive either general anesthesia or infraclavicular brachial plexus block
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Able to provide written and verbal informed consent

You may not qualify if:

  • Age \<18 years or \>65 years
  • Emergency surgery
  • Refusal or inability to provide informed consent
  • ASA physical status IV or V
  • Known bone diseases or metabolic bone disorders
  • Multiple trauma or associated organ injury
  • Inability to mobilize
  • Morbid obesity (BMI \>40 kg/m²)
  • Renal failure
  • Hepatic failure
  • Neurological deficits or sequelae
  • Contraindication or allergy to any anesthetic agents used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • sumru sekerci, professor

    Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya

    STUDY DIRECTOR

Central Study Contacts

yusuf aynigul, resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 7, 2026

Study Start

January 25, 2026

Primary Completion

May 2, 2026

Study Completion

May 5, 2026

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified aggregate data will be reported in publications.