Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Osteoarthritis of the Knee Clinical Trial

Official title:

Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562627
• Other study ID #: 2007-003030-41
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2007
• Last updated: August 5, 2011
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2011
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.

2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

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:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.

2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ropivacaine
intraoperative and 1. postoperative day
• adrenaline
intraoperative LIA (IV and IA) and continuous EDA
• ketorolac
intraoperative and 1. postoperative day
• morphine
intraoperative
• fentanyl
continuous postoperatively
• bupivacaine
continuous postoperatively

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at Rest (VAS)	VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.	48 hours postoperative	No
Secondary	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.	48 hours postoperative	No
Secondary	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.	up to 10 days postoperative	No