Effect of Anesthesia in Fracture Healing

Study Overview
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Brief Summary
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Investigator' s study designed to investigate effect of general and regional anesthesia on fracture healing.The 40 age and older ASAI-III patients who will operate due to femur fracture (except femur neck fracture) will be enrolled in this study after informed consent approval. Subjects will be divided into two groups by a computerized randomization method. 40 patients will be enrolled in this study. General anesthesia will perform for 20 patients. Regional anesthesia will perform for 20 patients. Preoperative, 4. week and 12. weeks laboratory test which include blood and urine β-C terminal telopeptid (β-CTX), blood alkaline phosphatase and osteocalcin will test for all patients. All patients will not use nonsteroid anti-inflammatory drugs during study neither perioperative nor postoperative periods. fracture healing will be asses with clinical evaluation and laboratory tests.

Detailed Description
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Investigator' s study designed to investigate effect of general and regional anesthesia on fracture healing.The 40 age and older ASAI-III patients who will operate due to femur fracture (except femur neck fracture) will be enrolled in this study after informed consent approval. Subjects will be divided into two groups by a computerized randomization method. 40 patients will be enrolled in this study. Each group will have 20 patients. However a pilot study will perform for each groups with 10 patients. In Group G, all patients will be applied general anesthesia and 2 mg/kg propofol and 0,6 mg/kg rocuronium will administer to patients for induction of anesthesia. Maintenance of anesthesia will be made with %50-%50 O2/N2O and %2 sevoflurane. 0,1 mg/kg morphine will be held on last 10 minutes of operation for postoperative analgesia. Also, patient controlled analgesia with morphine(1 mg bolus and 20 min lockout time) will apply for postoperative analgesia. If it is necessary additional analgesic will provide with 100 mg peroral and intravenous tramadol. Regional anesthesia will perform for 20 patients which named Group R. In Group R combined epidural-spinal anesthesia will perform. Spinal %5 bupivacain 15 mg and 20µg fentanyl will apply and analgesia will provide with epidural bupivacain. Preoperative, 4. week and 12. weeks laboratory test which include blood and urine β-C terminal telopeptid (β-CTX), blood alkaline phosphatase and osteocalcin will all patients. All patients will not use nonsteroid antiinflammatory drugs during study neither perioperative nor postoperative periods. Fracture healing will be asses with clinical evaluation and laboratory tests. All measurements will be assessed with statistically.

Official Title
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Effect of General and Regional Anesthesia on Fracture Healing

Conditions
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Closed Fracture of Hip

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ASA I-III Patients who will be operated for femur fracture 40 age and up patients Exclusion Criteria: patients ASAIV and Up Haemodynamic unstable patients No patient's approval Femur neck fractures

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br>General Anesthesia: Effect of general anesthesia will compare with regional anesthesia without use of nonsteroid antiinflammatory drug usage. Propofol 2mg/kg and rocuronium will be administered to patients for anesthesia induction. Anesthesia maintenance will ensure with sevoflurane %2 and N2O/O2 %50/50 mixture. | Drug: Sevoflurane<br>* Anesthesia type of performed for patient which has femur fracture.<br>* Other names: general anesthesia;|
| Active Comparator: bupivacaine<br>Regional Anesthesia: Effect of regional anesthesia will compare with general anesthesia without use of nonsteroid antiinflammatory drug usage. Combined epidural-spinal anesthesia will be performed to patients. %5 bupivacain and 20µg fentanyl will apply for spinal anesthesia. Anesthesia maintenance will ensure with bupivacain. | Drug: Bupivacaine<br>* Anesthesia type of performed for patient which has femur fracture.<br>* Other names: regional anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover markers level-β-C terminal telopeptid (β-CTX) | Patients will follow until postoperative 12. weeks. β-C terminal telopeptid (β-CTX)(ng/mL or pg/mL) level will asses at preoperative, 4. week and 12. week | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover markers level-osteocalcin | Patients will follow until postoperative 12. weeks.Osteocalcin (pg/mL) level will asses at preoperative, 4. week and 12. week | up to 12. weeks | 
| Bone turnover markers level-bone alkaline phosphatase | Patients will follow until postoperative 12. weeks.Bone alkaline phosphatase (U/L) level will asses at preoperative, 4. week and 12. week | up to 12. weeks | 
| Walking quality | Patients will follow until postoperative 12. weeks. Walking Quality will asses with clinical evaluation. With walker, with support( guided walk), full independent walk | up to 12. weeks |