Continuous Saphenous Nerve Block for Total Knee Arthroplasty
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
continuous saphenous nerve block
Saline boluses in nerve catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Anaestesiafdelingen, Frederiksberg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Saline boluses in nerve catheter
Continuous saphenous nerve block
Arm Description
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Outcomes
Primary Outcome Measures
Pain scores
VAS pain scores
Secondary Outcome Measures
Opioid consumption
physical therapy progress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01332045
Brief Title
Continuous Saphenous Nerve Block for Total Knee Arthroplasty
Official Title
Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Lykke Andersen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.
The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.
If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline boluses in nerve catheter
Arm Type
Sham Comparator
Arm Description
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Arm Title
Continuous saphenous nerve block
Arm Type
Active Comparator
Arm Description
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Intervention Type
Procedure
Intervention Name(s)
continuous saphenous nerve block
Intervention Description
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Intervention Type
Procedure
Intervention Name(s)
Saline boluses in nerve catheter
Intervention Description
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Primary Outcome Measure Information:
Title
Pain scores
Description
VAS pain scores
Time Frame
3 days postoperative
Secondary Outcome Measure Information:
Title
Opioid consumption
Time Frame
3 days postoperative
Title
physical therapy progress
Time Frame
3 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning L. Andersen, M.D.
Organizational Affiliation
Frederiksberg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dusanka Zaric, M.D., Ph.d.
Organizational Affiliation
Frederiksberg Hospital.
Official's Role
Study Director
Facility Information:
Facility Name
Anaestesiafdelingen, Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23222363
Citation
Andersen HL, Gyrn J, Moller L, Christensen B, Zaric D. Continuous saphenous nerve block as supplement to single-dose local infiltration analgesia for postoperative pain management after total knee arthroplasty. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):106-11. doi: 10.1097/AAP.0b013e31827900a9.
Results Reference
derived
Links:
URL
http://www.frederiksberghospital.dk
Description
Related Info
Learn more about this trial
Continuous Saphenous Nerve Block for Total Knee Arthroplasty
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