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Completed

NCT Number: NCT02621255

Effect of Anesthesia in Fracture Healing

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ebru Biricik

Adana, Sarıçam, 01380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sevoflurane

Drug

Anesthesia type of performed for patient which has femur fracture.

Other names: general anesthesia

Bupivacaine

Drug

Anesthesia type of performed for patient which has femur fracture.

Other names: regional anesthesia

Primary outcomes

  1. Bone turnover markers level-β-C terminal telopeptid (β-CTX)

    Time frame: up to 12 weeks

    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

Secondary outcomes

  1. Bone turnover markers level-osteocalcin

    Time frame: up to 12. weeks

    Patients will follow until postoperative 12. weeks.Osteocalcin (pg/mL) level will asses at preoperative, 4. week and 12. week

  2. Bone turnover markers level-bone alkaline phosphatase

    Time frame: up to 12. weeks

    Patients will follow until postoperative 12. weeks.Bone alkaline phosphatase (U/L) level will asses at preoperative, 4. week and 12. week

  3. Walking quality

    Time frame: up to 12. weeks

    Patients will follow until postoperative 12. weeks. Walking Quality will asses with clinical evaluation. With walker, with support( guided walk), full independent walk

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Effect of General and Regional Anesthesia on Fracture Healing

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Nov 21, 2017

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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