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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
Asker & Baerum Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 21, 2007
Last Updated
August 5, 2011
Sponsor
Asker & Baerum Hospital
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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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