A Phase 4 interventional study of Ropivacaine and Placebo in Postoperative Pain Management, sponsored by Region Skane. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2014-11-26.
Sponsored by Region Skane · Phase 4, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 200 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
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The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.
Drug: Ropivacaine
The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.
Drug: Placebo
100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour
Also known as: Naropin, Narop
Change in postoperative pain
The patient are asked to grade their pain on a VAS-scale (0-100)twice daily for the first 4 days after the TKA operation and at the 2 weeks follow-up. Changes in pain during this time frame are recorded to see if there are any differences between the two groups.
Time frame: The first 4 postoperative days at noon and 8 PM
Extra oral analgesia consumption
All extra analgesia consumption are noted during the first 4 postoperative days. All patients have a standard pain management medication (depending on weight, age and sex) and only extra doses are noted.
Time frame: First 4 postoperative days
Number of postoperative days in hospital
The number of days the patient needs to stay in hospital after operation are noted
Time frame: Duration of hospital stay, an expected time frame of 4-5 days
Pre- and postoperative knee range of motion
The range of motion in the affected knee are registered with a goniometer at the preoperative admission for operation, about 2 weeks prior to the operation and then on day 4, 14 and 30 postoperatively.
Time frame: At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively
Postoperative complications
All complications postoperatively are registered for the first 2 years.
Time frame: 2 years postoperatively
Knee specific and general questionaire
The patients are asked to fill out the general health questionaire EQ-5D as well as the knee specific questionaire KOOS preoperatively at the admission for surgery (about 2 weeks before the operation) and at 1 and 2 year follow up.
Time frame: preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Region Skane