Clinical trial NCT01726686: Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump
Official title: Evaluation of Intra-articular Continuous Infusion Pump With Ropivacaine in Addition to Local Infiltration Analgesia (LIA) in Total Knee Arthroplasty (TKA). A Placebo Controlled Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Management
Keywords: Total Knee Arthroplasty
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given.

Detailed description: 200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are entered into the study. All patients are given a standard protocol of analgesics pre- and postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get an epidural type of catheter intraarticular with a coupled continuous infusion pump that delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100 placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software randomized to receive either active or placebo pump. Only one nurse, not involved in neither the operation nor the after treatment, has the key to what substance it is in the numbered pumps. Thus, it is a double blinded trial during the whole follow up period. Before the operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the operation the patients are monitored at the ward by the nurses and physiotherapists. The level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up. The number of days the patients need to stay in hospital after operation are registered. The amount of extra doses of analgesics the patient requires are registered as well as the complications (illness, wound problems, infections etc). The patients are to be followed clinically for 2 years as well as with outcome questionnaires.

Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the knee necessitating total knee replacement
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* Known allergy to local anaesthetics or other contraindication for the use of local anaesthetics.
* Treatment with Warfarin.
* Bilateral operation

Primary outcomes:
measure: Change in postoperative pain
timeFrame: The first 4 postoperative days at noon and 8 PM
Secondary outcomes:
measure: Extra oral analgesia consumption
timeFrame: First 4 postoperative days
Other outcomes:
measure: Number of postoperative days in hospital
timeFrame: Duration of hospital stay, an expected time frame of 4-5 days
measure: Pre- and postoperative knee range of motion
timeFrame: At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively
measure: Postoperative complications
timeFrame: 2 years postoperatively
measure: Knee specific and general questionaire
timeFrame: preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively
Locations:
city: Lund
country: Sweden
facility: Department of Orthopedics, Skane University Hospital, Lund University
Study officials:
affiliation: Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
name: Gunnar Flivik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: