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

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Department of Orthopedics, Skåne University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The first 4 postoperative days at noon and 8 PM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 4 postoperative days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of postoperative days in hospital	The number of days the patient needs to stay in hospital after operation are noted	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.	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.	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.	preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: LIA-Pump_AA