Trial Outcomes & Findings for Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study (NCT NCT01620047)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

24 hours post-surgery

Results posted on

2013-11-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).	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).	Intravenous Fentanyl 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).
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femoral Nerve Fentanyl n=20 Participants 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).	Femoral Nerve Ropivacaine n=20 Participants 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).	Intravenous Fentanyl With Placebo n=20 Participants 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).	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Age Continuous	69 years STANDARD_DEVIATION 9 • n=5 Participants	67 years STANDARD_DEVIATION 12 • n=7 Participants	67 years STANDARD_DEVIATION 9 • n=5 Participants	68 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours post-surgery

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Femoral Nerve Fentanyl n=20 Participants 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).	Femoral Nerve Ropivacaine n=20 Participants 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).	Intravenous Fentanyl With Placebo n=20 Participants 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).
Comparison of Postoperative Strength (Extension)	.08 Nm/kg Interval 0.01 to 0.28	.03 Nm/kg Interval 0.01 to 0.17	.05 Nm/kg Interval 0.0 to 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours post-surgery

To identify a difference in serum fentanyl levels among the groups.

Outcome measures

Outcome data not reported

Adverse Events

Femoral Nerve Fentanyl

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Femoral Nerve Ropivacaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Intravenous Fentanyl With Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Femoral Nerve Fentanyl n=20 participants at risk 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).	Femoral Nerve Ropivacaine n=20 participants at risk 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).	Intravenous Fentanyl With Placebo n=20 participants at risk 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).
Gastrointestinal disorders Nausea	45.0% 9/20	25.0% 5/20	50.0% 10/20

Additional Information

Director of Research

Gulf-to-Bay Anesthesiology Associates LLC

Phone: 813-844-4413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place