Sponsor study identifier
interventional
164
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
October 2010
Actual (reported)The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery. With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities. Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure. When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming. The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
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October 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 2010
Actual (reported)October 2010
Actual (reported)September 2, 2011
Actual (reported)September 28, 2011
Actual (reported)Cuff pressure (mmHg)
For patients in the control group the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. In the LOP group the tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) by using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus
participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days
Quality of bloodless field
Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)
particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days
Postoperative pain
The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery
Range of motion (ROM)
The participants were examined at third postoperative day and at the two months follow up after surgery
Postoperative wound complications
The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery
EMG/EnEG
Participans were examined day three and two months postoperatively
the Standard method;tourniquet pressure based on systolic blood pressure, plus a safety margin.
cuff pressure is based on limb occlusion pressure measurement
The tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus (Zimmer Sweden Inc®).
Standard method at our department, the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon.
Department of clinical science and education, Södersjukhuset
Stockholm, 11883, Sweden
164 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2011
First Posted
September 28, 2011
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
July 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
September 28, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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