NCT01795287

Brief Summary

There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

7.8 years

First QC Date

February 15, 2013

Last Update Submit

April 16, 2019

Conditions

Tibial Fracture

Keywords

tibial fractureintramedullary nailingspinal anesthesiapatient safety

Outcome Measures

Primary Outcomes (1)

  • Compartment pressure

    Continuous measurement of anterior compartment pressure in the operated leg

    0-24 hours after surgery

Secondary Outcomes (1)

  • INVOS values after surgery

    0-24 hours after surgery

Study Arms (2)

Spinal anesthesia

ACTIVE COMPARATOR

Spinal anesthesia

Procedure: General anesthesiaProcedure: Spinal anesthesia

General anesthesia

ACTIVE COMPARATOR

General anesthesia with fentanyl, propofol and rocuronium and sevoflurane

Procedure: General anesthesiaProcedure: Spinal anesthesia

Interventions

General anesthesiaPROCEDURE

GA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium.

General anesthesiaSpinal anesthesia
Spinal anesthesiaPROCEDURE

hyperbaric bupivacaine 10-15 mg i.t.

General anesthesiaSpinal anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a unilateral tibial shaft fracture which needs to be operated are included.

You may not qualify if:

  • refusal of the patient
  • severe, generalized atherosclerosis
  • massive obesity
  • marked mental retardation, dementia
  • bilateral tibial shaft fracture
  • polytrauma, such as head injury
  • bleeding diathesis
  • aortic stenosis
  • infection at the injection site
  • certain medications affecting bleeding
  • sepsis
  • hypovolemia
  • conversion to general anaesthesia due to technical difficulties
  • anesthesiologist has a strong opinion towards GA/RA
  • foreign patient and marked translation difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

RECRUITING

Related Publications (1)

  • Lehto PM, Vakkala MA, Lantto IP, Ohtonen P, Liisanantti JH, Kaakinen TI. Spinal Anaesthesia Versus General Anaesthesia for Patients With Tibia Shaft Fractures-A Randomized Controlled Study. Acta Anaesthesiol Scand. 2025 Sep;69(8):e70111. doi: 10.1111/aas.70111.

    PMID: 40792424DERIVED

MeSH Terms

Conditions

Tibial Fractures

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Officials

  • Timo Kaakinen, MD, PhD

    Oulu University Hospital

    STUDY DIRECTOR

Central Study Contacts

Timo Kaakinen, MD, PhD

CONTACT

+358405939190timo.kaakinen@fimnet.fi

Merja Vakkala, MD, PhD

CONTACT

+358442915787merja.vakkala@ppshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 20, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

FI(1)