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Effect of Anesthesia in Fracture Healing

Primary Purpose

Closed Fracture of Hip

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Bupivacaine
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture of Hip

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ebru Biricik

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General anesthesia

bupivacaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 26, 2015
Last Updated
November 19, 2017
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT02621255
Brief Title
Effect of Anesthesia in Fracture Healing
Official Title
Effect of General and Regional Anesthesia on Fracture Healing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
general anesthesia
Intervention Description
Anesthesia type of performed for patient which has femur fracture.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
regional anesthesia
Intervention Description
Anesthesia type of performed for patient which has femur fracture.
Primary Outcome Measure Information:
Title
Bone turnover markers level-β-C terminal telopeptid (β-CTX)
Description
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
Secondary Outcome Measure Information:
Title
Bone turnover markers level-osteocalcin
Description
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
Title
Bone turnover markers level-bone alkaline phosphatase
Description
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
Title
Walking quality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ersel Güleç
Organizational Affiliation
Çukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ebru Biricik
City
Adana
State/Province
Sarıçam
ZIP/Postal Code
01380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15804493
Citation
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.
Results Reference
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PubMed Identifier
24788647
Citation
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.
Results Reference
background
PubMed Identifier
21808683
Citation
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.
Results Reference
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Effect of Anesthesia in Fracture Healing

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