Trial Outcomes & Findings for Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS) (NCT NCT04171050)
NCT ID: NCT04171050
Last Updated: 2025-06-03
Results Overview
Measured in morphine milligram equivalents (MME) at 24 hours
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
24 hours after surgery
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
Group 1: Local Anesthesia
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Baseline characteristics by cohort
| Measure |
Group 1: Local Anesthesia
n=22 Participants
This group was assigned usual care, which involved local anesthesia administered per surgeon preference
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
66 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Refused to answer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgeryMeasured in morphine milligram equivalents (MME) at 24 hours
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=22 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Narcotic Use
|
8 MME
Interval 0.0 to 20.0
|
6.75 MME
Interval 0.0 to 15.0
|
PRIMARY outcome
Timeframe: 48 hours after surgeryMeasured in MME at 48 hours
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=22 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Narcotic Use
|
8 MME
Interval 0.0 to 26.0
|
7 MME
Interval 0.0 to 35.0
|
SECONDARY outcome
Timeframe: 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours, 24 hours, and 48 hours after surgeryPopulation: Patients were not present for 8-12 hour assessment (outpatient surgery so they were sent home)
Average pain score by Numerical Rating Scale (NRS). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=22 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Pain Scores
0-2 hours
|
1.2 score on a scale
Standard Deviation 1.8
|
1.6 score on a scale
Standard Deviation 2.4
|
|
Pain Scores
48 hours
|
3 score on a scale
Standard Deviation 2
|
4 score on a scale
Standard Deviation 3
|
|
Pain Scores
2-4 hours
|
1.4 score on a scale
Standard Deviation 1.7
|
1.1 score on a scale
Standard Deviation 1.8
|
|
Pain Scores
4-8 hours
|
1.9 score on a scale
Standard Deviation 1.8
|
1.4 score on a scale
Standard Deviation 2.0
|
|
Pain Scores
24 hours
|
4 score on a scale
Standard Deviation 2
|
3 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 6 weeks after surgeryDays to return to normal activity, defined as walking, sitting, and performing daily household tasks comfortably. Upon discharge, all participants received a diary to record the date they returned to normal daily activities. Participants were contacted at 2 and 6 weeks postoperatively either by telephone or during their scheduled office visit and were asked about their time to return to normal activity.
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=22 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Return to Normal Daily Activities
|
10 Days
Interval 6.0 to 18.0
|
10 Days
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: 48 hours after surgery, 2 weeks after surgeryPopulation: Participants who completed the study, per Participant Flow.
Satisfaction with postoperative pain control was assessed using a verbal scale of 1=very satisfied, 2=Somewhat satisfied, 3=Neither satisfied nor dissatisfied, 4=Somewhat dissatisfied, 5=very dissatisfied
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=21 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=21 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Patient Satisfaction With Postoperative Recovery
5 - at 2 weeks
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction With Postoperative Recovery
Not obtained at 2 weeks
|
2 Participants
|
0 Participants
|
|
Patient Satisfaction With Postoperative Recovery
1 - at 48 hours
|
16 Participants
|
13 Participants
|
|
Patient Satisfaction With Postoperative Recovery
1 - at 2 weeks
|
15 Participants
|
17 Participants
|
|
Patient Satisfaction With Postoperative Recovery
2 - at 2 weeks
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Postoperative Recovery
3 - at 2 weeks
|
2 Participants
|
0 Participants
|
|
Patient Satisfaction With Postoperative Recovery
4 - at 2 weeks
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction With Postoperative Recovery
2 - at 48 hours
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction With Postoperative Recovery
3 - at 48 hours
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction With Postoperative Recovery
4 - at 48 hours
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Postoperative Recovery
5 - at 48 hours
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction With Postoperative Recovery
Not obtained at 48 hours
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Tracked by hour through time of patient discharge (up to 72 hours)Tracked in hours
Outcome measures
| Measure |
Group 1: Local Anesthesia
n=22 Participants
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 Participants
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Length of Hospital Stay
|
16.5 Hours
Interval 4.5 to 24.0
|
9 Hours
Interval 5.0 to 23.0
|
Adverse Events
Group 1: Local Anesthesia
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Local Anesthesia Plus Pudendal Nerve Block
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Local Anesthesia
n=22 participants at risk
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 participants at risk
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
General disorders
hospital readmission
|
0.00%
0/22 • 6 weeks postoperatively
|
4.5%
1/22 • Number of events 1 • 6 weeks postoperatively
|
Other adverse events
| Measure |
Group 1: Local Anesthesia
n=22 participants at risk
Standard of care with local anesthesia used during surgery
Local anaesthetic: Local anesthesia injections
|
Group 2: Local Anesthesia Plus Pudendal Nerve Block
n=22 participants at risk
Pudendal Nerve Block (PNB) in addition to local anesthesia used during surgery
Pudendal Nerve Block plus anesthesia: Local anesthesia injections plus a pudendal nerve block
|
|---|---|---|
|
Surgical and medical procedures
Pudendal nerve entrapment
|
0.00%
0/22 • 6 weeks postoperatively
|
4.5%
1/22 • Number of events 1 • 6 weeks postoperatively
|
|
General disorders
Postoperative nausea
|
4.5%
1/22 • Number of events 1 • 6 weeks postoperatively
|
0.00%
0/22 • 6 weeks postoperatively
|
|
Injury, poisoning and procedural complications
Anesthetic complication
|
4.5%
1/22 • Number of events 1 • 6 weeks postoperatively
|
0.00%
0/22 • 6 weeks postoperatively
|
|
Renal and urinary disorders
Urinary retention at 48hr
|
18.2%
4/22 • Number of events 4 • 6 weeks postoperatively
|
27.3%
6/22 • Number of events 6 • 6 weeks postoperatively
|
Additional Information
Tamara Grisales, MD
University of California, Los Angeles
Phone: 310-983-1023
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place