NCT02621255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

November 26, 2015

Last Update Submit

November 19, 2017

Conditions

Closed Fracture of Hip

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bone turnover markers level-osteocalcin

    up to 12. weeks

  • Bone turnover markers level-bone alkaline phosphatase

    up to 12. weeks

  • Walking quality

    up to 12. weeks

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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

bupivacaine

ACTIVE COMPARATOR

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

Interventions

SevofluraneDRUG

Anesthesia type of performed for patient which has femur fracture.

Also known as: general anesthesia
General anesthesia
BupivacaineDRUG

Anesthesia type of performed for patient which has femur fracture.

Also known as: regional anesthesia
bupivacaine

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ASA I-III
  • Patients who will be operated for femur fracture
  • age and up patients

You may not qualify if:

  • patients ASAIV and Up
  • Haemodynamic unstable patients
  • No patient's approval
  • Femur neck fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Biricik

Adana, Sarıçam, 01380, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 15804493BACKGROUND

  • 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.

    PMID: 24788647BACKGROUND

  • 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.

    PMID: 21808683BACKGROUND

MeSH Terms

Interventions

SevofluraneAnesthesia, GeneralBupivacaineAnesthesia, Conduction

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Ersel Güleç

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 3, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)