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Clinical Trials/NCT00653926
NCT00653926
Completed
N/A

Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty

Region Örebro County1 site in 1 country40 target enrollmentSeptember 2005

Overview

Phase
N/A
Intervention
ropivacaine, ketorelac and epinephrine
Conditions
Postoperative Pain
Sponsor
Region Örebro County
Enrollment
40
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
September 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Region Örebro County

Eligibility Criteria

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

Arms & Interventions

A

Group A (Active) receives a multimodal injection intra- and postoperatively

Intervention: ropivacaine, ketorelac and epinephrine

P

Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively

Intervention: saline

Outcomes

Primary Outcomes

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.

Time Frame: April, 2007

Secondary Outcomes

  • 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)

Study Sites (1)

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