A Phase 4 interventional study of Sevoflurane and Bupivacaine in Closed Fracture of Hip, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Cukurova University · Phase 4, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Anesthesia type of performed for patient which has femur fracture.
Also known as: general anesthesia
Anesthesia type of performed for patient which has femur fracture.
Also known as: regional anesthesia
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
Time frame: up to 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: up to 12. weeks
Plan to share: No
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Sevoflurane · Bupivacaine