Trial Outcomes & Findings for Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty (NCT NCT02701296)
NCT ID: NCT02701296
Last Updated: 2018-10-03
Results Overview
Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
48 hours post surgery
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Posterior Capsular Injection
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
42
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Posterior Capsular Injection
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Overall Study
Incomplete Data
|
0
|
2
|
Baseline Characteristics
Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
63.5 Years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
64.8 Years
STANDARD_DEVIATION 8.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
36 participants
n=107 Participants
|
78 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hours post surgeryMean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Pain Intensity
PACU Admission
|
3.5 pain score
Standard Deviation 2.95
|
3.2 pain score
Standard Deviation 3.67
|
|
Pain Intensity
PACU Discharge
|
2.1 pain score
Standard Deviation 1.78
|
1.5 pain score
Standard Deviation 1.73
|
|
Pain Intensity
6th hour
|
1.9 pain score
Standard Deviation 1.85
|
2.0 pain score
Standard Deviation 2.17
|
|
Pain Intensity
12th hour
|
2.0 pain score
Standard Deviation 2.36
|
1.2 pain score
Standard Deviation 2.03
|
|
Pain Intensity
18th hour
|
2.3 pain score
Standard Deviation 2.21
|
3.2 pain score
Standard Deviation 2.36
|
|
Pain Intensity
24th hour
|
2.7 pain score
Standard Deviation 2.21
|
3.4 pain score
Standard Deviation 2.42
|
|
Pain Intensity
30th hour
|
2.6 pain score
Standard Deviation 2.40
|
3.0 pain score
Standard Deviation 2.43
|
|
Pain Intensity
36th hour
|
2.5 pain score
Standard Deviation 2.46
|
2.7 pain score
Standard Deviation 2.53
|
|
Pain Intensity
42nd hour
|
3.2 pain score
Standard Deviation 1.82
|
3.2 pain score
Standard Deviation 2.5
|
|
Pain Intensity
48th hour
|
2.5 pain score
Standard Deviation 1.98
|
3.4 pain score
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 24 hours post surgeryPopulation: Mean consumption of Hydromorphone(mg) post-op day 1
Amount of opioid used for the first 24 hours post surgery
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Opioid Consumption
|
0.33 mg
Standard Deviation 0.655
|
0.42 mg
Standard Deviation 0.706
|
SECONDARY outcome
Timeframe: Upon emergence from anesthesia in the PACUBlinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Plantar Flexion in the Tibial Nerve Distribution
Complete Motor Block
|
1 Participants
|
0 Participants
|
|
Plantar Flexion in the Tibial Nerve Distribution
Partial Motor Block
|
3 Participants
|
25 Participants
|
|
Plantar Flexion in the Tibial Nerve Distribution
No Motor Block
|
38 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Upon emergence from anesthesia in the PACUNumber of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Cold Sensation in the Tibial Nerve Distribution
Complete Sensory Block
|
1 Participants
|
6 Participants
|
|
Cold Sensation in the Tibial Nerve Distribution
Partial Sensory Block
|
7 Participants
|
27 Participants
|
|
Cold Sensation in the Tibial Nerve Distribution
No Sensory Block
|
34 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Upon emergence from anesthesia in the PACUNumber of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Dorsiflexion in the Peroneal Nerve Distribution
Complete Motor Block
|
0 Participants
|
0 Participants
|
|
Dorsiflexion in the Peroneal Nerve Distribution
Partial Motor Block
|
1 Participants
|
4 Participants
|
|
Dorsiflexion in the Peroneal Nerve Distribution
No Motor Block
|
41 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Upon emergence from anesthesia in the PACUNumber of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)
Outcome measures
| Measure |
Posterior Capsular Injection
n=42 Participants
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
|
Tibial Nerve Block
n=36 Participants
Ultrasound selective tibial nerve block of ropivacaine
Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
|
|---|---|---|
|
Sensation in the Peroneal Nerve Distribution
Complete Sensory Block
|
2 Participants
|
1 Participants
|
|
Sensation in the Peroneal Nerve Distribution
Partial Sensory Block
|
3 Participants
|
11 Participants
|
|
Sensation in the Peroneal Nerve Distribution
No Sensory Block
|
37 Participants
|
24 Participants
|
Adverse Events
Posterior Capsular Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tibial Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place