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

NCT01726686 | Completed Phase 4

• 1 other identifier: LIA-Pump_AA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Management

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extra oral analgesia consumption

  First 4 postoperative days

Other Outcomes (4)

• Number of postoperative days in hospital

  Duration of hospital stay, an expected time frame of 4-5 days

• Pre- and postoperative knee range of motion

  At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively

• Postoperative complications

  2 years postoperatively

Study Arms (2)

Ropivacaine in the pump

ACTIVE COMPARATOR

The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.

Drug: Ropivacaine

Placebo in the pump

PLACEBO COMPARATOR

The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.

Drug: Placebo

Interventions

Ropivacaine DRUG

100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour

Also known as: Naropin, Narop

Ropivacaine in the pump

Placebo DRUG

Placebo in the pump

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Orthopedics, Skane University Hospital, Lund University

Lund, Sweden

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gunnar Flivik, MD PhD

  Dept of Orthopedics, Skane University Hospital, Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD PhD

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 15, 2012
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: April 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

SE (1)