Tibial FractureNCT01795287
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
A study testing General anesthesia and Spinal anesthesia in people with Tibial Fracture, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- General anesthesia and Spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a unilateral tibial shaft fracture which needs to be operated are included.
Who cannot join
- refusal of the patient
- severe, generalized atherosclerosis
- massive obesity
- marked mental retardation, dementia
- bilateral tibial shaft fracture
- polytrauma, such as head injury
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, 90029
Timo Kaakinen, MD, PhD, +358405939190, timo.kaakinen@fimnet.fi
About this study
Official title: Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture: A Single-center Randomized, Controlled Trial.
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.
Read the 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.
- Conditions
- Tibial Fracture
- Being tested
- General anesthesia, Spinal anesthesia
- Keywords
- tibial fracture, intramedullary nailing, spinal anesthesia, patient safety
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
GA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium.
Spinal anesthesiaProcedure or surgery
hyperbaric bupivacaine 10-15 mg i.t.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Active comparator | Spinal anesthesia Receives: Procedure: General anesthesia; Procedure: Spinal anesthesia |
| General anesthesia | Active comparator | General anesthesia with fentanyl, propofol and rocuronium and sevoflurane Receives: Procedure: General anesthesia; Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compartment pressure
Continuous measurement of anterior compartment pressure in the operated leg
Measured: 0-24 hours after surgery
Secondary outcomes (1)
INVOS values after surgery
Continuous monitoring of INVOS values in the anterior and postolateral position in the operated leg
Measured: 0-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timo Kaakinen, MD, PhD, Study director, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795287
- Sponsor's protocol ID
- kaakinen001
- Status last verified
- Apr 2019
- First submitted
- 15 Feb 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40792424
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture: A Single-center Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01795287
- Acronym / sponsor ID
- kaakinen001
- Conditions
- Tibial Fracture
- Keywords
- tibial fracture, intramedullary nailing, spinal anesthesia, patient safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Active comparator | Procedure: General anesthesia, Procedure: Spinal anesthesiaSpinal anesthesia |
| General anesthesia | Active comparator | Procedure: General anesthesia, Procedure: Spinal anesthesiaGeneral anesthesia with fentanyl, propofol and rocuronium and sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a unilateral tibial shaft fracture which needs to be operated are included.
Key exclusion criteria (15 listed)
- refusal of the patient
- severe, generalized atherosclerosis
- massive obesity
- marked mental retardation, dementia
- bilateral tibial shaft fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaGA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium. | Procedure or surgery | General anesthesia, Spinal anesthesia |
| Spinal anesthesiahyperbaric bupivacaine 10-15 mg i.t. | Procedure or surgery | General anesthesia, Spinal anesthesia |
Primary outcome
Compartment pressure
Time frame: 0-24 hours after surgery
Continuous measurement of anterior compartment pressure in the operated leg
1 secondary outcome
INVOS values after surgery
Time frame: 0-24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 40792424Lehto 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.
Related trials for Tibial Fracture
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Kaakinen, MD, PhD study director
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Spinal anesthesia in people with Tibial Fracture, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo Kaakinen, MD, PhD (+358405939190, timo.kaakinen@fimnet.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compartment pressure (time frame: 0-24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.