Trial Outcomes & Findings for Pudendal Nerve Block for Hemorrhoidectomy (NCT NCT04251884)
NCT ID: NCT04251884
Last Updated: 2022-03-11
Results Overview
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
at 24 hours after the hemorrhoidectomy
Results posted on
2022-03-11
Participant Flow
Participant milestones
| Measure |
Receiving the Pudendal Nerve Block
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
No ultrasound-guided pudendal block performed
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
26
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 18.3 • n=23 Participants
|
53.3 years
STANDARD_DEVIATION 17.5 • n=26 Participants
|
52.5 years
STANDARD_DEVIATION 17.7 • n=49 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=23 Participants
|
11 Participants
n=26 Participants
|
22 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=23 Participants
|
15 Participants
n=26 Participants
|
27 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
23 Participants
n=23 Participants
|
26 Participants
n=26 Participants
|
49 Participants
n=49 Participants
|
|
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy)
• Cardiologic disease
|
2 participants
n=23 Participants
|
3 participants
n=26 Participants
|
5 participants
n=49 Participants
|
|
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy)
• Pulmonary disease
|
0 participants
n=23 Participants
|
3 participants
n=26 Participants
|
3 participants
n=49 Participants
|
|
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy)
• Kidney disease
|
2 participants
n=23 Participants
|
1 participants
n=26 Participants
|
3 participants
n=49 Participants
|
|
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy)
• Diabetes
|
1 participants
n=23 Participants
|
2 participants
n=26 Participants
|
3 participants
n=49 Participants
|
|
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy)
• Neuropathy
|
0 participants
n=23 Participants
|
1 participants
n=26 Participants
|
1 participants
n=49 Participants
|
|
Symptoms leading to surgery (itching, pain, bleeding, tenesmus)
Itching
|
10 participants
n=23 Participants
|
9 participants
n=26 Participants
|
19 participants
n=49 Participants
|
|
Symptoms leading to surgery (itching, pain, bleeding, tenesmus)
Pain
|
20 participants
n=23 Participants
|
23 participants
n=26 Participants
|
43 participants
n=49 Participants
|
|
Symptoms leading to surgery (itching, pain, bleeding, tenesmus)
Bleeding
|
12 participants
n=23 Participants
|
19 participants
n=26 Participants
|
31 participants
n=49 Participants
|
|
Symptoms leading to surgery (itching, pain, bleeding, tenesmus)
Tenesmus
|
2 participants
n=23 Participants
|
2 participants
n=26 Participants
|
4 participants
n=49 Participants
|
PRIMARY outcome
Timeframe: at 24 hours after the hemorrhoidectomyVisual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Outcome measures
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
|---|---|---|
|
Postoperative Pain on the Visual Analogue Scale (VAS)
|
1.4 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: at 6, 12 and 48 hours after the operationVisual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Outcome measures
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
|---|---|---|
|
Postoperative Pain on the Visual Analogue Scale (VAS)
Pain on VAS at 6 hours
|
2.8 score on a scale
Standard Deviation 2.4
|
4.6 score on a scale
Standard Deviation 3.7
|
|
Postoperative Pain on the Visual Analogue Scale (VAS)
Pain on VAS at 12 hours
|
3.4 score on a scale
Standard Deviation 3.1
|
4.7 score on a scale
Standard Deviation 3.6
|
|
Postoperative Pain on the Visual Analogue Scale (VAS)
Pain on VAS at 48 hours
|
1.0 score on a scale
Standard Deviation 1.6
|
2.1 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Within 48 hoursOutcome measures
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
|---|---|---|
|
Opioids Consumption
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 2 weeksOutcome measures
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
|---|---|---|
|
Lenght of Hospital Stay
|
1.2 days
Standard Deviation 1.2
|
1.8 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Within 6 weeksOutcome measures
| Measure |
Receiving the Pudendal Nerve Block
n=23 Participants
Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.
|
Not Receiving the Pudendal Nerve Block
n=26 Participants
No ultrasound-guided pudendal nerve block performed.
|
|---|---|---|
|
Complications Related to the Pudendal Nerve Block
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the hospital stayOngoing
Outcome measures
Outcome data not reported
Adverse Events
Receiving the Pudendal Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Receiving the Pudendal 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