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Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Region Skane.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gunnar Flivik, Region Skane
ClinicalTrials.gov Identifier:
NCT01726686
First received: October 30, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain Management
Drug: Ropivacaine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Change in postoperative pain [ Time Frame: The first 4 postoperative days at noon and 8 PM ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Extra oral analgesia consumption [ Time Frame: First 4 postoperative days ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of postoperative days in hospital [ Time Frame: Duration of hospital stay, an expected time frame of 4-5 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ropivacaine
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.
Drug: Placebo

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726686

Locations
Sweden
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Gunnar Flivik, MD PhD Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
  More Information

No publications provided

Responsible Party: Gunnar Flivik, Associate Professor, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01726686     History of Changes
Other Study ID Numbers: LIA-Pump_AA
Study First Received: October 30, 2012
Last Updated: November 9, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Total Knee Arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014