- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01187537
Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement (PCA)
May 12, 2016 updated by: Chan Ee Yuee, Tan Tock Seng Hospital
Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement
The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.
Study Overview
Detailed Description
Primary Outcome Measures:
- Incidence of patients with significant pain on movement on day 1 post surgery
- Range of knee flexion
Secondary Outcome Measures:
- Pain intensity (rest/movement)
- Functional recovery
- Knee Injury and Osteoarthritis Score
- Side effects/ Adverse outcomes
- SF12 Quality of Life Questionnaire
- Length of stay
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore
- Tan Tock Seng Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 40 years and above
- Osteoarthritis
- Primary unilateral total knee replacement
- No other lower extremity joint disease
- ASA I-III
- Body mass index < 35
- No severe cardiac or pulmonary diseases
- No chronic narcotic therapy or illicit drug use
- Mentally competent to understand study procedures and use of pain scales
- Able to provide informed consent
Exclusion Criteria:
- Any cause for knee replacement other than osteoarthritis
- Total knee revision
- Any contraindication for femoral block
- Abnormal coagulation studies
- Thrombocytopenia less than 100,000/cc
- Known hepatic or renal insufficiency
- Neurological disease involving lower extremities
- Major surgery during the last 2 weeks pre-operatively
- History of allergy to study medications
- History of post-operative bleeding over 2000 cc/24 hours
- History of opioid or alcohol abuse
- Currently taking or has taken opioid > 30 consecutive days of daily use at a daily dose > 15mg morphine, within the past 2 weeks prior to surgery
- Previously has not responded to opioid analgesics for treatment of pain
- Pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Femoral Nerve Block
|
20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml)
If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr.
If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
Other Names:
|
Active Comparator: Single-Inj Nerve Block with IV PCA
|
20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml)
If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr.
If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
Other Names:
|
Active Comparator: IV PCA
|
20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml)
If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr.
If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of patients with significant pain on movement on day 1 post surgery
Time Frame: Post op day 1
|
Post op day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional recovery
Time Frame: During hospitalization, week 2, week 12
|
During hospitalization, week 2, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ee Yuee Chan, Tan Tock Seng Hospital
- Principal Investigator: Nelson Chua, Tan Tock Seng Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 22, 2010
First Submitted That Met QC Criteria
August 23, 2010
First Posted (Estimate)
August 24, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIG/09052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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