Clinical trial NCT01442298: A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty
Official title: A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Arthroplasty
Keywords: bloodless field
cuff pressure
limb occlusion pressure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 164
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Planned for total knee arthroplasty in bloodless field
* 75 year or younger

Exclusion Criteria:

* Patients unable to read and understand Swedish
* Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.

Primary outcomes:
measure: Cuff pressure (mmHg)
timeFrame: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days
measure: Quality of bloodless field
timeFrame: particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery
measure: Range of motion (ROM)
timeFrame: The participants were examined at third postoperative day and at the two months follow up after surgery
measure: Postoperative wound complications
timeFrame: The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery
measure: EMG/EnEG
timeFrame: Participans were examined day three and two months postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of clinical science and education, Södersjukhuset
Study officials:
References: