Evaluation of Irisin Levels in Adult Forearm Fracture Surgery Under Infraclavicular Block and General Anesthesia
1 other identifier
interventional
90
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
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
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
January 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2026
CompletedJanuary 9, 2026
December 1, 2025
3 months
December 24, 2025
January 7, 2026
Conditions
Keywords
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 COMPARATORAdult 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.
Infraclavicular Block (ICB) Group
EXPERIMENTALAdult 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.
Interventions
General anesthesia administered according to institutional routine; anesthetic drugs and doses will be recorded.
Ultrasound-guided infraclavicular block performed preoperatively; details of technique, local anesthetic drugs and doses will be recorded.
Eligibility Criteria
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.
PMID: 22237023RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
sumru sekerci, professor
Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya
Central Study Contacts
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.