Post-op Pain Clinical Trial
Official title:
Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
NCT number | NCT01939379 |
Other study ID # | 5130183 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | July 25, 2017 |
Verified date | April 2021 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 25, 2017 |
Est. primary completion date | July 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Is the subject undergoing primary unilateral total knee arthroplasty? 2. Is the subject 18 to 99 years of age? 3. Is the subject ASA class 1, 2, or 3? 4. Does the subject have a BMI less than 35? 5. Can the subject consent in the English language? Exclusion Criteria: 1. Does subject have an allergy to drugs used in this study; 2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone? 3. Does subject have a history of alcohol or drug abuse 4. Has subject had a previous total knee arthroplasty? 5. Has subject had any neurologic deficits in the lower extremity being studied? |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center East Campus Hospital | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opiate pain medication | At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome | The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery. | |
Secondary | Patient satisfaction with pain control | Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose. | We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery |
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