CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Fentanyl +2 moredrug
Likely dose
Fentanyl 3 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01620047
NCT01620047N/ACompleted

Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study

University of South Florida·interventional·Posted Jun 15, 2012·Updated Nov 11, 2013

In Brief

A clinical study evaluating Fentanyl and Ropivacaine for Total Knee Replacement and Primary Knee Arthroplasty. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Major surgery involving the knee is often associated with severe postoperative pain. Postoperative pain control remains a significant contributor to delayed recovery and length of hospital stay. Approaches to minimize postoperative pain after surgery are a matter of major concern due to the need for early mobilization, a crucial factor in good postoperative rehabilitation. Femoral nerve blocks by either continuous infusion or single injection of anesthetics provide an effective method for analgesia while minimizing the need for systemic opioid therapy, reducing the opioid induced side effects, and facilitating early ambulation. Administration of fentanyl has shown to be a highly effective method to control pain after Total Knee Replacement (TKR). The investigators hypothesize that fentanyl infusions will result in greater post-operative strength in the operative knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2012
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.0 years ago

Interventions

Fentanyldrug

Fentanyl 3 µg/ml continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU)through a femoral nerve sheath catheter.

Ropivacainedrug

Ropivacaine 0.1% delivered through a femoral nerve sheath catheter continuously for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).

Fentanyldrug

0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).