Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Primary Purpose
Tibial Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
General anesthesia
Spinal anesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Tibial Fracture focused on measuring tibial fracture, intramedullary nailing, spinal anesthesia, patient safety
Eligibility 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
Sites / Locations
- Oulu University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spinal anesthesia
General anesthesia
Arm Description
Spinal anesthesia
General anesthesia with fentanyl, propofol and rocuronium and sevoflurane
Outcomes
Primary Outcome Measures
Compartment pressure
Continuous measurement of anterior compartment pressure in the operated leg
Secondary Outcome Measures
INVOS values after surgery
Continuous monitoring of INVOS values in the anterior and postolateral position in the operated leg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01795287
Brief Title
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Official Title
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture: A Single-center Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
Keywords
tibial fracture, intramedullary nailing, spinal anesthesia, patient safety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal anesthesia
Arm Type
Active Comparator
Arm Description
Spinal anesthesia
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
General anesthesia with fentanyl, propofol and rocuronium and sevoflurane
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
GA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
hyperbaric bupivacaine 10-15 mg i.t.
Primary Outcome Measure Information:
Title
Compartment pressure
Description
Continuous measurement of anterior compartment pressure in the operated leg
Time Frame
0-24 hours after surgery
Secondary Outcome Measure Information:
Title
INVOS values after surgery
Description
Continuous monitoring of INVOS values in the anterior and postolateral position in the operated leg
Time Frame
0-24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timo Kaakinen, MD, PhD
Phone
+358405939190
Email
timo.kaakinen@fimnet.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Merja Vakkala, MD, PhD
Phone
+358442915787
Email
merja.vakkala@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Kaakinen, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Kaakinen, MD, PhD
Phone
+358405939190
Email
timo.kaakinen@fimnet.fi
12. IPD Sharing Statement
Learn more about this trial
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
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