Primary Knee Arthroplasty, Total Knee Replacement
Conditions
Keywords
Regional Anesthesia, Post-operative pain management, Femoral Nerve Block, Total Knee Replacement
Brief 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.
Detailed description
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.
Interventions
DRUGFentanyl
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.
DRUGRopivacaine
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).
Sponsors
Tampa General Hospital
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing unilateral primary total knee replacement * ASA class I-III * 18 years and older
Exclusion criteria
* Patient refusal * Pregnancy * Coagulopathy * Adverse/allergic reaction to any opioids or local anesthetics * History of long-term opioid use (greater than 60 days) * Infection * Traumatic lower extremity injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Postoperative Strength (Extension) | 24 hours post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Scores and Postoperative Supplemental Morphine Consumption | 24 hours post-surgery | 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. |
| Serum Fentanyl Levels | 24 hours post-surgery | To identify a difference in serum fentanyl levels among the groups. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Femoral Nerve Fentanyl 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). | 20 |
| Femoral Nerve Ropivacaine 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). | 20 |
| Intravenous Fentanyl With Placebo 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). | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Femoral Nerve Ropivacaine | Intravenous Fentanyl With Placebo | Femoral Nerve Fentanyl | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 15 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 5 Participants | 21 Participants |
| Age Continuous | 67 years STANDARD_DEVIATION 12 | 67 years STANDARD_DEVIATION 9 | 69 years STANDARD_DEVIATION 9 | 68 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 11 Participants | 38 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 20 | 5 / 20 | 10 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Nerve Fentanyl | Comparison of Postoperative Strength (Extension) | .08 Nm/kg |
| Femoral Nerve Ropivacaine | Comparison of Postoperative Strength (Extension) | .03 Nm/kg |
| Intravenous Fentanyl With Placebo | Comparison of Postoperative Strength (Extension) | .05 Nm/kg |
Secondary
Serum Fentanyl Levels
To identify a difference in serum fentanyl levels among the groups.
Time frame: 24 hours post-surgery
Secondary
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