Clinical trial NCT00653926: Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty
Official title: Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Local infiltration analgesia
Knee arthroplasty
Postoperative pain management following unicompartmental knee arthroplasty
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2008-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: April, 2007
Secondary outcomes:
measure: 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.
timeFrame: September, 2007
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Dept. of Orthopedic Surgery and Anesthesia and Intensive Care
Study officials:
affiliation: Orebro University Hospital, Orebro, Sweden
name: Kjell Axelsson, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Essving P, Axelsson K, Kjellberg J, Wallgren O, Gupta A, Lundin A. Reduced hospital stay, morphine consumption, and pain intensity with local infiltration analgesia after unicompartmental knee arthroplasty. Acta Orthop. 2009 Apr;80(2):213-9. doi: 10.3109/17453670902930008.