An interventional study of Fentanyl and Ropivacaine in Total Knee Replacement and Primary Knee Arthroplasty, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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.
All subjects scheduled to receive a unilateral, primary total knee replacement were evaluated for eligibility in the preoperative anesthesia center. Adults, older than 18 years of age, ASA I-III were included in the study. Subjects who were either pregnant, on anticoagulant therapy, allergic to opioids, local anesthetics, chronic pain patients, history of traumatic lower extremity injury, or had a body mass index of greater than 35 kg/m2 were excluded from the study.
University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were 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).
Drug: Fentanyl
Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were 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).
Drug: Ropivacaine
Control group which received 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. All study drugs were 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).
Drug: Fentanyl
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.
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).
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).
Comparison of Postoperative Strength (Extension)
To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.
Time frame: 24 hours post-surgery
VAS Scores and Postoperative Supplemental Morphine Consumption
Secondary Objective * To determine the amount of required supplemental analgesia during the postoperative period. * To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line.
Time frame: 24 hours post-surgery
Serum Fentanyl Levels
To identify a difference in serum fentanyl levels among the groups.
Time frame: 24 hours post-surgery
This was a prospective, randomized, double-blinded study performed between April and November 2011. Patients were recruited in the pre-operative clinic 3 to 7 days prior to undergoing a total knee replacement.
| Milestone | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 |
To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.
| Nm/kg | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo |
|---|---|---|---|
| Comparison of Postoperative Strength (Extension) | .08 (0.01 to 0.28) | .03 (0.01 to 0.17) | .05 (0 to 0.13) |
Secondary Objective * To determine the amount of required supplemental analgesia during the postoperative period. * To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line.
Results for this outcome have not been posted.
To identify a difference in serum fentanyl levels among the groups.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Femoral Nerve Fentanyl | — | 0/20 (0%) | 9/20 (45%) |
| Femoral Nerve Ropivacaine | — | 0/20 (0%) | 5/20 (25%) |
| Intravenous Fentanyl With Placebo | — | 0/20 (0%) | 10/20 (50%) |
| Event | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 9/20 | 5/20 | 10/20 |
| Age, Categorical(Participants) | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 8 | 8 | 21 |
| >=65 years | 15 | 12 | 12 | 39 |
| Age Continuous(years) | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo | Total |
|---|---|---|---|---|
| Mean | 69 ± 9 | 67 ± 12 | 67 ± 9 | 68 ± 10 |
| Sex: Female, Male(Participants) | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo | Total |
|---|---|---|---|---|
| Female | 11 | 13 | 14 | 38 |
| Male | 9 | 7 | 6 | 22 |
| Region of Enrollment(participants) | Femoral Nerve Fentanyl | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo | Total |
|---|---|---|---|---|
| United States | 20 | 20 | 20 | 60 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of South Florida