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Tibial Fracture | Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

Tibial Fracture research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: Patients with a unilateral tibial shaft fracture which needs to be operated are included. Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Tibial Fracture

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:General anesthesiaGA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium.

Procedure:Spinal anesthesiahyperbaric bupivacaine 10-15 mg i.t.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Spinal anesthesiaSpinal anesthesia

General anesthesiaGeneral anesthesia with fentanyl, propofol and rocuronium and sevoflurane

Study Status

Recruiting

Start Date: March 2012

Completed Date: June 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Compartment pressure

Secondary Outcome: INVOS values after surgery

Study sponsors, principal investigator, and references

Principal Investigator: Timo Kaakinen, MD, PhD

Lead Sponsor: University of Oulu

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01795287

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