Local Infiltration Analgesia Following Total Knee Arthroplasty

Not Applicable

Completed

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

• Registration Number: NCT00799175
• 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 morphine consumption. Secondary end-points are hospital stay, 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 3 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. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

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 morphine consumption. Secondary end-points are hospital stay, 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 3 months after surgery.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2008-11
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Last Update Submitted: 2008-11-26
• Study First Posted: 2008-11-27
• Last Update Posted: 2008-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Patients scheduled for total knee arthroplasty
• Aged 20-85 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
2 Group P (Placebo)	saline	Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
1 Group A(Active)	ropivacaine, ketorolac and epinephrine	Group A (Active) receives a multimodal injection intra- and postoperatively

Primary Outcome Measures

Name	Time	Method
Morphine consumption	0-48 hours

Secondary Outcome Measures

Name	Time	Method
hospital stay, pain intensity, side effects, knee function and patient satisfaction scores	0-3 months

Trial Locations

Locations (1)

University Hospital Orebro; 🇸🇪 Orebro, Sweden