Effect of Anesthesia in Fracture Healing

Effect of General and Regional Anesthesia on 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.

Study Overview

• Status: Completed
• Conditions: Closed Fracture of Hip
• Intervention / Treatment: Drug: Sevoflurane; Drug: Bupivacaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sarıçam
    • Adana, Sarıçam, Turkey, 01380
      • Ebru Biricik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia; 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; Anesthesia type of performed for patient which has femur fracture.; Other Names: general anesthesia
Active Comparator: bupivacaine; 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.; Other Names: regional anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Ersel Güleç, Cukurova University

Publications and helpful links

General Publications

• Obrant KJ, Ivaska KK, Gerdhem P, Alatalo SL, Pettersson K, Vaananen HK. Biochemical markers of bone turnover are influenced by recently sustained fracture. Bone. 2005 May;36(5):786-92. doi: 10.1016/j.bone.2005.02.009. Epub 2005 Mar 31.
• Wolfl C, Schweppenhauser D, Guhring T, Takur C, Honer B, Kneser U, Grutzner 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. Erratum In: PLoS One. 2022 Jun 13;17(6):e0270079.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 19, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Fractures, Closed; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, General; Platelet Aggregation Inhibitors; Anesthetics, Local; Anesthetics, Inhalation; Anesthetics; Sevoflurane; Bupivacaine
• Other Study ID Numbers: Fracture Healing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO