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Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

NCT01795287 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-17

No results posted yet for this study

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.

Conditions

  • Tibial Fracture

Interventions

PROCEDURE

General anesthesia

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

PROCEDURE

Spinal anesthesia

hyperbaric bupivacaine 10-15 mg i.t.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Timo Kaakinen, MD, PhD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795287 on ClinicalTrials.gov