Effect of Anesthesia in Fracture Healing

Closed Fracture of Hip Clinical Trial

Official title:

Effect of General and Regional Anesthesia on Fracture Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621255
• Other study ID #: Fracture Healing
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2015
• Last updated: November 19, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Closed Fracture of Hip
• Fractures, Bone
• Fractures, Closed
• Hip Fractures

Intervention

Drug:
• Sevoflurane
Anesthesia type of performed for patient which has femur fracture.
• Bupivacaine
Anesthesia type of performed for patient which has femur fracture.

Locations

Country	Name	City	State
Turkey	Ebru Biricik	Adana	Sariçam

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ikegami S, Kamimura M, Nakagawa H, Takahara K, Hashidate H, Uchiyama S, Kato H. Comparison in bone turnover markers during early healing of femoral neck fracture and trochanteric fracture in elderly patients. Orthop Rev (Pavia). 2009 Oct 10;1(2):e21. doi: 10.4081/or.2009.e21. — View Citation

Obrant KJ, Ivaska KK, Gerdhem P, Alatalo SL, Pettersson K, Väänänen HK. Biochemical markers of bone turnover are influenced by recently sustained fracture. Bone. 2005 May;36(5):786-92. Epub 2005 Mar 31. — View Citation

Wölfl C, Schweppenhäuser D, Gühring T, Takur C, Höner B, Kneser U, Grützner PA, Kolios L. Characteristics of bone turnover in the long bone metaphysis fractured patients with normal or low Bone Mineral Density (BMD). PLoS One. 2014 May 1;9(5):e96058. doi: 10.1371/journal.pone.0096058. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover markers level-ß-C terminal telopeptid (ß-CTX)	Patients will follow until postoperative 12. weeks. ß-C terminal telopeptid (ß-CTX)(ng/mL or pg/mL) level will asses at preoperative, 4. week and 12. week	up to 12 weeks
Secondary	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
Secondary	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
Secondary	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