Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01795287
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Tibial Fracture
Procedure: General anesthesia
Procedure: Spinal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture: A Single-center Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Compartment pressure [ Time Frame: 0-24 hours after surgery ] [ Designated as safety issue: Yes ]
    Continuous measurement of anterior compartment pressure in the operated leg


Secondary Outcome Measures:
  • INVOS values after surgery [ Time Frame: 0-24 hours after surgery ] [ Designated as safety issue: Yes ]
    Continuous monitoring of INVOS values in the anterior and postolateral position in the operated leg


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spinal anesthesia
Spinal anesthesia
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.
Active Comparator: General anesthesia
General anesthesia with fentanyl, propofol and rocuronium and sevoflurane
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.

Detailed Description:

For some of the patients RA may be even more safe than GA. According to a large meta-analysis RA reduces the risk of several complications versus GA.

  • Risk of deep vein thrombosis is reduced by 44%
  • Risk of pulmonary embolism is reduced by 55 %
  • Risk of major bleeding is reduced by 50%
  • Risk of post operative pneumonia is reduced by 39%
  • Risk of post operative respiratory is reduced by 59%

It is generally thought that RA is safer than GA for example in patients with heart or pulmonary diseases. It is also known that the use of RA reduces postoperative need of opioids, which leads to improved respiratory function and reduced post operative disorientation, delirium and nausea.

Purpose of the study: Our purpose is to gain more information of the safety of RA in patients with tibial fracture. Our hypothesis is that RA is equally safe with GA.

Implementation: Research begins with a pilot study in which RA is compared with GA. There are about 65 tibial fractures operated in our centre every year. We randomize patients to GA group (n=25) and spinal anaesthesia group (n=25). We presume that RA is equally safe with GA. However, power analysis has been made presuming that RA will increase the risk of ACS. We calculated the sample size by assuming that the compartment pressure in RA group is 10 mmHg higher than in the GA group.

GA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium. Spinal-anaesthesia will be performed by using hyperbaric bupivacaine. The dose is 10-15 mg, depending on the needs of the patient. This will maintain RA in lower extremities for 2-4 hours, which is enough to operate a tibial shaft fracture. In both study groups the post-operative pain will be treated by intravenous and peroral oxycodone and paracetamol.

Monitoring and ethics:

  • Clinical examination every hour in recovery room (oedema, temperature, cutaneous sensation, distal pulses)
  • Continuous pressure-measurement of anterior compartment in the operated leg for 24 hours
  • Local oxygen metabolism measured by near-infrared spectroscopy in the operated leg for 24 hours

Patients will be monitored in the recovery room for 24 hours after operation. Blood tests (creatine kinase and myoglobin) will be drawn before operation, when arriving in recovery room, 6 hours and 24 hours after operation in each patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795287

Contacts
Contact: Timo Kaakinen, MD, PhD +358405939190 timo.kaakinen@fimnet.fi
Contact: Merja Vakkala, MD, PhD +358442915787 merja.vakkala@ppshp.fi

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Timo Kaakinen, MD, PhD    +358405939190    timo.kaakinen@fimnet.fi   
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Timo Kaakinen, MD, PhD Oulu University Hospital
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01795287     History of Changes
Other Study ID Numbers: kaakinen001
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
tibial fracture
intramedullary nailing
spinal anesthesia
patient safety

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014