Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: saline; Drug: ropivacaine, ketorelac and epinephrine

• Registration Number: NCT00653926
• Lead Sponsor: Region Örebro County

Brief Summary

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 6 months after surgery.

Detailed Description

Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-03
• Study Completion: 2007-09
• Status Verified: 2008-04
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-04
• Last Update Submitted: 2008-04-04
• Study First Posted: 2008-04-07
• Last Update Posted: 2008-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients scheduled for unicompartmental knee arthroplasty
• Aged 20-80 yrs.
• ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria

• Known allergy or intolerance to one of the study drugs
• Serious liver-, heart- or renal decease
• Rheumatoid arthritis
• Chronic pain or bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	saline	Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
A	ropivacaine, ketorelac and epinephrine	Group A (Active) receives a multimodal injection intra- and postoperatively

Primary Outcome Measures

Name	Time	Method
The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay.	April, 2007

Secondary Outcome Measures

Name	Time	Method
Secondary end-points were morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores were assessed up to 6 months after surgery.	September, 2007

Trial Locations

Locations (1)

Dept. of Orthopedic Surgery and Anesthesia and Intensive Care; 🇸🇪 Orebro, Sweden