|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01332045 |
|
Date of registration:
|
07/04/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Continuous Saphenous Nerve Block for Total Knee Arthroplasty
|
|
Scientific title:
|
Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01332045 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Henning L. Andersen, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Frederiksberg Hospital |
|
|
Name:
|
Dusanka Zaric, M.D., Ph.d. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Frederiksberg Hospital. |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- ASA I-III
- Age: 40-75
- Unilateral TKA
- Use of Spinal anesthesia
Exclusion Criteria:
- Allergy to any of the study medications
- Intolerance to morphine
- Contraindication to a spinal anesthetic
- Intraoperative use of any volatile anesthetic
- Chronic opioid use
- ASA Class 4-5
- Rheumatoid arthritis or Diabetes mellitus with neuropathy
- Liver or kidney failure
- BMI above 40
- Severe COPD
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain, Postoperative
|
|
Intervention(s)
|
|
Procedure: continuous saphenous nerve block
|
|
Procedure: Saline boluses in nerve catheter
|
|
Primary Outcome(s)
|
|
Pain scores
[Time Frame: 3 days postoperative]
|
|
Secondary Outcome(s)
|
|
Opioid consumption
[Time Frame: 3 days postoperative]
|
|
physical therapy progress
[Time Frame: 3 days postoperative]
|
|
Secondary ID(s)
|
|
H-3-2010-124
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|