Evaluation of Irisin Levels in Adult Forearm Fracture Surgery Under Infraclavicular Block and General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: General Anesthesia (GA), Infraclavicular Brachial Plexus Blocks.
- Who it may be relevant to
- Registry conditions: Inflamation, Healing, Angiogenesis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Irisin Levels in Adult Patients With Forearm Fractures Undergoing Surgery With Infraclavicular Block and General Anesthesia
Overview
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.
Detailed description
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.
Interventions
- Procedure General Anesthesia (GA)
General anesthesia administered according to institutional routine; anesthetic drugs and doses will be recorded. - Procedure Infraclavicular Brachial Plexus Blocks
Ultrasound-guided infraclavicular block performed preoperatively; details of technique, local anesthetic drugs and doses will be recorded.
Primary outcome measures
- Change in Serum Irisin Levels [Time frame: Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively]
Secondary outcome measures (1)
- Radiological Fracture Healing and Callus Formation [Time frame: Postoperative follow-up period (up to 6 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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 22237023
Identifiers
NCT: NCT07324681 · TABED 1-25-1099