Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
ropivacaine
adrenaline
ketorolac
morphine
fentanyl
bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery
Eligibility Criteria
Inclusion Criteria:
- patients at least 18 years of age
- scheduled for elective total knee arthroplasty
- ASA I-III
- signed written informed consent
Exclusion Criteria:
- age < 18
- ASA > III
- moderate or severe cardiac disease, bronchial asthma
- allergy against ropivacaine, ketorolac or morphine
- analgetic abuse
- pregnancy or nursing women
- severe psychiatric disease
- moderate to severe dementia
Sites / Locations
- Asker and Baerum Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
LIA IV
LIA IA
EDA
Arm Description
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
standard continuous epidural analgesia
Outcomes
Primary Outcome Measures
Pain at Rest (VAS)
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
Secondary Outcome Measures
Opioid Use
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Time to Readiness for Discharge
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
Full Information
NCT ID
NCT00562627
First Posted
November 21, 2007
Last Updated
August 5, 2011
Sponsor
Asker & Baerum Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00562627
Brief Title
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Official Title
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asker & Baerum Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
Detailed Description
Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:
Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee arthroplasty, local infiltration analgesia, TKA, epidural analgesia, operation, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIA IV
Arm Type
Experimental
Arm Description
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
Arm Title
LIA IA
Arm Type
Experimental
Arm Description
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
Arm Title
EDA
Arm Type
Active Comparator
Arm Description
standard continuous epidural analgesia
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
intraoperative and 1. postoperative day
Intervention Type
Drug
Intervention Name(s)
adrenaline
Other Intervention Name(s)
Adrenalin, (epinephrine)
Intervention Description
intraoperative LIA (IV and IA) and continuous EDA
Intervention Type
Drug
Intervention Name(s)
ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
intraoperative and 1. postoperative day
Intervention Type
Drug
Intervention Name(s)
morphine
Other Intervention Name(s)
Morfin
Intervention Description
intraoperative
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
continuous postoperatively
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
Marcain
Intervention Description
continuous postoperatively
Primary Outcome Measure Information:
Title
Pain at Rest (VAS)
Description
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Opioid Use
Description
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
Time Frame
48 hours postoperative
Title
Time to Readiness for Discharge
Description
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
Time Frame
up to 10 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients at least 18 years of age
scheduled for elective total knee arthroplasty
ASA I-III
signed written informed consent
Exclusion Criteria:
age < 18
ASA > III
moderate or severe cardiac disease, bronchial asthma
allergy against ropivacaine, ketorolac or morphine
analgetic abuse
pregnancy or nursing women
severe psychiatric disease
moderate to severe dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich J Spreng, MD
Organizational Affiliation
Asker and Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asker and Baerum Hospital
City
Rud
ZIP/Postal Code
1309
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
20736233
Citation
Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.
Results Reference
derived
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Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
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