Management of Postoperative Pain After Total Knee Replacement.
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|ClinicalTrials.gov Identifier: NCT01163214|
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : November 5, 2014
Last Update Posted : November 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Knee Replacement Arthroplasty||Drug: Nerve Block Drug: Periarticular Injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Nerve Block
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Drug: Nerve Block
Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
Other Name: Naropin
Active Comparator: Periarticular Injection
Injection combination prior to skin closure.
Drug: Periarticular Injection
Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
- Post-Operative Pain [ Time Frame: Afternoon on post-operative Day 1, approximately 14:00 ]Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
- Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment) [ Time Frame: Afternoon on post-operative Day 1, approximately 14:00 ]Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
- Narcotic Use [ Time Frame: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2 ]Use of additional narcotic medications (as needed), measured in morphine equivalents.
- Straight-leg Raise [ Time Frame: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon ]Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
- Length of Stay in Hospital [ Time Frame: Approximately 2 days after surgery ]Length of stay data were calculated from the medical record.
- Number of Subjects Who Experienced Neurological Changes Postoperatively [ Time Frame: 6 weeks postoperative ]Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163214
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Mark J Spangehl, M.D.||Mayo Clinic|