Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ropivacaine, ketorelac and epinephrine
saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Local infiltration analgesia, Knee arthroplasty, Postoperative pain management following unicompartmental knee arthroplasty
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
Sites / Locations
- Dept. of Orthopedic Surgery and Anesthesia and Intensive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
P
Arm Description
Group A (Active) receives a multimodal injection intra- and postoperatively
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653926
Brief Title
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
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Region Örebro County
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Local infiltration analgesia, Knee arthroplasty, Postoperative pain management following unicompartmental knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Group A (Active) receives a multimodal injection intra- and postoperatively
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Group P (Placebo) receives no injection intraoperatively and a saline injection postoperatively
Intervention Type
Drug
Intervention Name(s)
ropivacaine, ketorelac and epinephrine
Intervention Description
In Group A, 200 mg ropivicaine, 30 mg ketorelac and 0.5 mg epinephrine (total volume 106 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation in the following way: Before inserting the components, 20-30 ml are injected into the posterior capsule and before closure of the wound the rest is injected into the capsule incision, the synovium, the ligament and the subcutaneous tissue After 21 postoperative hours in Group A, 150 mg ropivicaine, 30 mg ketorelac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
In Group P (placebo) no injections were given intaoperatively. All patients had a tunnelled intra-articular multihole 20-G catheter placed at the end of the operation by the surgeon.After 21 postoperative hours 22 ml of saline was injected intraarticularly via the catheter.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Time Frame
September, 2007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Prof.
Organizational Affiliation
Orebro University Hospital, Orebro, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Orthopedic Surgery and Anesthesia and Intensive Care
City
Orebro
ZIP/Postal Code
SE-70185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19404806
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.
Results Reference
derived
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Local Infiltration Analgesia Following Unicompartmental Knee Arthroplasty
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