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NCT Number: NCT07324681

Evaluation of Irisin Levels in Adult Forearm Fracture Surgery Under Infraclavicular Block and General Anesthesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Forearm fractures are common injuries in adults and frequently require surgical intervention due to instability and displacement. Postoperative recovery quality and fracture healing are influenced by multiple factors, including the type of anesthesia administered during surgery. However, the biochemical and metabolic effects of different anesthesia techniques on bone healing remain insufficiently explored.

Irisin is a myokine derived from the cleavage of fibronectin type III domain-containing protein 5 (FNDC5) and plays a significant role in muscle-bone crosstalk. Experimental and clinical studies have demonstrated that irisin promotes osteoblast differentiation, inhibits osteocyte apoptosis, and contributes to bone homeostasis and fracture healing. Despite its potential importance, the relationship between anesthesia techniques and perioperative irisin levels has not been previously investigated.

This single-center, randomized, prospective clinical trial aims to compare the effects of general anesthesia and infraclavicular brachial plexus block on perioperative serum irisin levels in adult patients undergoing elective forearm fracture surgery. Patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to one of two groups: general anesthesia (Group G) or infraclavicular block (Group B).

Serum irisin levels will be measured at three time points: preoperatively, 30 minutes postoperatively, and 24 hours postoperatively. In addition to biochemical outcomes, intraoperative hemodynamic parameters (heart rate, blood pressure, oxygen saturation), analgesic consumption, and demographic data will be recorded. Postoperative radiographs will be evaluated to monitor fracture healing and callus formation, which will be analyzed as a secondary outcome in relation to changes in irisin levels.

The primary outcome of the study is the comparison of perioperative changes in serum irisin levels between the two anesthesia techniques. Secondary outcomes include the relationship between irisin level changes and radiological fracture healing, as well as differences in perioperative physiological stress responses.

This study aims to improve understanding of the metabolic and biochemical effects of anesthesia techniques on bone healing. The findings may contribute to the selection of anesthesia methods that minimize physiological stress and potentially enhance postoperative recovery and fracture healing in patients undergoing forearm fracture surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

General Anesthesia (GA)

Procedure

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

Infraclavicular Brachial Plexus Blocks

Procedure

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

Primary outcomes

  1. Change in Serum Irisin Levels

    Time frame: Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively

    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.

Secondary outcomes

  1. Radiological Fracture Healing and Callus Formation

    Time frame: Postoperative follow-up period (up to 6 months)

    Postoperative radiographs will be evaluated to assess fracture healing and callus formation. Radiological findings will be analyzed in relation to perioperative changes in serum irisin levels to explore a potential association between irisin response and fracture healing.

Study contacts

Contact information is provided by the study sponsor or research team.

yusuf aynigul, resident

CONTACT

[email protected]

+905522096781

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Evaluation of Irisin Levels in Adult Patients With Forearm Fractures Undergoing Surgery With Infraclavicular Block and General Anesthesia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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