Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795287
Status:
UNKNOWN
Last Update Posted:
2019-04-17
First Post:
2013-02-15
Brief Title:
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture
Sponsor:
University of Oulu
Organization:
University of Oulu
Study Overview
Official Title:
Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture A Single-center Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n25 and spinal anaesthesia group n25 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
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 n25 and spinal anaesthesia group n25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None