Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump
|ClinicalTrials.gov Identifier: NCT01726686|
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : November 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Management||Drug: Ropivacaine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||April 2014|
Active Comparator: Ropivacaine in the pump
The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.
100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour
Other Name: Naropin, Narop
Placebo Comparator: Placebo in the pump
The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.
- Change in postoperative pain [ Time Frame: The first 4 postoperative days at noon and 8 PM ]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.
- Extra oral analgesia consumption [ Time Frame: First 4 postoperative days ]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.
- Number of postoperative days in hospital [ Time Frame: Duration of hospital stay, an expected time frame of 4-5 days ]The number of days the patient needs to stay in hospital after operation are noted
- Pre- and postoperative knee range of motion [ Time Frame: At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively ]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.
- Postoperative complications [ Time Frame: 2 years postoperatively ]All complications postoperatively are registered for the first 2 years.
- Knee specific and general questionaire [ Time Frame: preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726686
|Department of Orthopedics, Skane University Hospital, Lund University|
|Principal Investigator:||Gunnar Flivik, MD PhD||Dept of Orthopedics, Skane University Hospital, Lund University, Sweden|