Trial Outcomes & Findings for PENG Block Versus LP Block for THA Postop Pain (NCT NCT05261009)
NCT ID: NCT05261009
Last Updated: 2024-05-21
Results Overview
a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
hour 6
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Peri-capsular Nerve Group (PENG)
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PENG Block Versus LP Block for THA Postop Pain
Baseline characteristics by cohort
| Measure |
Peri-capsular Nerve Group (PENG)
n=76 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=76 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
Total
n=152 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
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
76 participants
n=7 Participants
|
152 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: hour 6a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain.
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
|
4.0 units on a scale
Standard Deviation 2.8
|
2.8 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: hour 12a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 12 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
NRS Pain Score
|
6.1 units on a scale
Standard Deviation 2.4
|
5.0 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: hour 18a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 18 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
NRS Pain Score
|
6.0 units on a scale
Standard Deviation 2.8
|
5.3 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: hour 24a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 24 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
NRS Pain Score
|
5.7 units on a scale
Standard Deviation 2.2
|
4.6 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: hour 24Population: The number analyzed for pain meds in each group is different from the participant flow because not everyone had to have opioids within the first 24 hours. This outcome is related to only those that required opioids in each group.
Time to first dose of opioid rescue for postoperative pain management - This outcome was evaluated in time to first opioid dose, which was measured in hours - no analysis for mean, median, or any of the others suggested - It was calculated as time of block to time of first opioid dose-hours and minutes.
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=72 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=70 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Time in Minutes Until Opioid Administration
|
464.98 minutes until first dose
Standard Deviation 221.67
|
394.69 minutes until first dose
Standard Deviation 158.39
|
SECONDARY outcome
Timeframe: hour 6straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Motor Strength
|
3.5 units on a scale
Standard Deviation 1.6
|
2.4 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: hour 24Recorded in feet during first physical therapy
Outcome measures
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 Participants
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 Participants
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Distance Ambulated
|
59.1 feet
Standard Deviation 49.6
|
43.9 feet
Standard Deviation 42.2
|
Adverse Events
Peri-capsular Nerve Group (PENG)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Lumbar Plexus Block (LPB)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peri-capsular Nerve Group (PENG)
n=75 participants at risk
Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management
|
Lumbar Plexus Block (LPB)
n=75 participants at risk
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.
Lumbar Plexus Block (LPB): LPB for postoperative pain management
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Right hip dislocation
|
1.3%
1/75 • Number of events 1 • 24 hour follow up of evaluating adverse events
|
0.00%
0/75 • 24 hour follow up of evaluating adverse events
|
|
Blood and lymphatic system disorders
Pumonary embolism
|
0.00%
0/75 • 24 hour follow up of evaluating adverse events
|
1.3%
1/75 • Number of events 1 • 24 hour follow up of evaluating adverse events
|
|
Musculoskeletal and connective tissue disorders
epidural spread
|
0.00%
0/75 • 24 hour follow up of evaluating adverse events
|
1.3%
1/75 • Number of events 1 • 24 hour follow up of evaluating adverse events
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place