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Local Infiltration Analgesia Following Total Knee Arthroplasty (RAK-total)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ropivacaine, ketorolac and epinephrine
saline
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Local infiltration analgesia, Knee arthroplasty

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Orebro
  • University Hospital Orebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 Group A(Active)

2 Group P (Placebo)

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

Morphine consumption

Secondary Outcome Measures

hospital stay, pain intensity, side effects, knee function and patient satisfaction scores

Full Information

First Posted
November 26, 2008
Last Updated
November 26, 2008
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT00799175
Brief Title
Local Infiltration Analgesia Following Total Knee Arthroplasty
Acronym
RAK-total
Official Title
Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Group A(Active)
Arm Type
Active Comparator
Arm Description
Group A (Active) receives a multimodal injection intra- and postoperatively
Arm Title
2 Group P (Placebo)
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, ketorolac and epinephrine
Intervention Description
In Group A, 400 mg ropivicaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 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, 200 mg ropivicaine, 30 mg ketorolac 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 intraoperatively. 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
Morphine consumption
Time Frame
0-48 hours
Secondary Outcome Measure Information:
Title
hospital stay, pain intensity, side effects, knee function and patient satisfaction scores
Time Frame
0-3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Prof
Organizational Affiliation
University Hospital Orebro, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Orebro
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
University Hospital Orebro
City
Orebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

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Local Infiltration Analgesia Following Total Knee Arthroplasty

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