- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07324681
Evaluation of Irisin Levels in Adult Forearm Fracture Surgery Under Infraclavicular Block and General Anesthesia
Evaluation of Irisin Levels in Adult Patients With Forearm Fractures Undergoing Surgery With Infraclavicular Block and General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yusuf aynigul, resident
- Phone Number: +905522096781
- Email: aynigulyusuff@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: General Anesthesia (GA) Group
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.
|
General anesthesia administered according to institutional routine; anesthetic drugs and doses will be recorded.
|
|
Experimental: Infraclavicular Block (ICB) Group
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.
|
Ultrasound-guided infraclavicular block performed preoperatively; details of technique, local anesthetic drugs and doses will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Postoperative follow-up period (up to 6 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: sumru sekerci, professor, Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED 1-25-1099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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