Pudendal Nerve Block for Hemorrhoidectomy

• Sponsor: Francesco Mongelli (Other)
• Overall Status: Completed
• CT.gov ID: NCT04251884
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids; Postoperative Pain	Procedure: Local anesthetic (ropivacaine)	N/A

Detailed Description

Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age < 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: RandomizedRandomized
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 29, 2019
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Receiving the pudendal nerve block	Procedure: Local anesthetic (ropivacaine); Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block; Other Names: No pudendal nerve block
Active Comparator: Not receiving the pudendal nerve block	Procedure: Local anesthetic (ropivacaine); Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block; Other Names: No pudendal nerve block

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain on the Visual Analogue Scale (VAS) [at 24 hours after the hemorrhoidectomy]

   Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"

Secondary Outcome Measures

1. Postoperative Pain on the Visual Analogue Scale (VAS) [at 6, 12 and 48 hours after the operation]

   Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"

2. Opioids Consumption [Within 48 hours]

3. Lenght of Hospital Stay [up to 2 weeks]

4. Complications Related to the Pudendal Nerve Block [Within 6 weeks]

5. Direct and Indirect Cost Analysis in Out- and In-patients [Within the hospital stay]

   Ongoing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia

• Signed informed consent

Exclusion criteria:

• Age < 18 years old

• Pregnancy

• Allergy to local anaesthetics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Regionale di Bellinzona e Valli	Bellinzona		Switzerland	6500

Sponsors and Collaborators

• Francesco Mongelli

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 8, 2018

More Information

Publications

None provided.

• Responsible Party: Francesco Mongelli, MD, Ospedale Regionale Bellinzona e Valli
• ClinicalTrials.gov Identifier: NCT04251884
• Other Study ID Numbers: CE TI 3222
• First Posted: Feb 5, 2020
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhoids; Ropivacaine; Anesthetics, Local; Anesthetics

Study Results

Participant Flow

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal block performed
Period Title: Overall Study
STARTED	23	26
COMPLETED	23	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block	Total
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.	Total of all reporting groups
Overall Participants	23	26	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.6 (18.3)	53.3 (17.5)	52.5 (17.7)
Sex: Female, Male (Count of Participants)
Female	11 47.8%	11 42.3%	22 44.9%
Male	12 52.2%	15 57.7%	27 55.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Switzerland	23 100%	26 100%	49 100%
Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) (participants) [Number]
• Cardiologic disease	2 8.7%	3 11.5%	5 10.2%
• Pulmonary disease	0 0%	3 11.5%	3 6.1%
• Kidney disease	2 8.7%	1 3.8%	3 6.1%
• Diabetes	1 4.3%	2 7.7%	3 6.1%
• Neuropathy	0 0%	1 3.8%	1 2%
Symptoms leading to surgery (itching, pain, bleeding, tenesmus) (participants) [Number]
Itching	10 43.5%	9 34.6%	19 38.8%
Pain	20 87%	23 88.5%	43 87.8%
Bleeding	12 52.2%	19 73.1%	31 63.3%
Tenesmus	2 8.7%	2 7.7%	4 8.2%

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain on the Visual Analogue Scale (VAS)
Description	Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Time Frame	at 24 hours after the hemorrhoidectomy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.
Measure Participants	23	26
Mean (Standard Deviation) [units on a scale]	1.4 (1.4)	3.1 (2.4)

2. Secondary Outcome

Title	Postoperative Pain on the Visual Analogue Scale (VAS)
Description	Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Time Frame	at 6, 12 and 48 hours after the operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.
Measure Participants	23	26
Pain on VAS at 6 hours	2.8 (2.4)	4.6 (3.7)
Pain on VAS at 12 hours	3.4 (3.1)	4.7 (3.6)
Pain on VAS at 48 hours	1.0 (1.6)	2.1 (2.0)

3. Secondary Outcome

Title	Opioids Consumption
Time Frame	Within 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block with performed 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.
Measure Participants	23	26
Count of Participants [Participants]	5 21.7%	10 38.5%

4. Secondary Outcome

Title	Lenght of Hospital Stay
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.
Measure Participants	23	26
Mean (Standard Deviation) [days]	1.2 (1.2)	1.8 (1.8)

5. Secondary Outcome

Title	Complications Related to the Pudendal Nerve Block
Time Frame	Within 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Receiving the Pudendal Nerve Block	Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.	No ultrasound-guided pudendal nerve block performed.
Measure Participants	23	26
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Direct and Indirect Cost Analysis in Out- and In-patients
Description	Ongoing
Time Frame	Within the hospital stay

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	Any adverse event related to the pudendal nerve block.
Arm/Group Title	Receiving the Pudendal Nerve Block		Not Receiving the Pudendal Nerve Block
Arm/Group Description	Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%.		No ultrasound-guided pudendal nerve block performed
All Cause Mortality
	Receiving the Pudendal Nerve Block		Not Receiving the Pudendal Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/26 (0%)
Serious Adverse Events
	Receiving the Pudendal Nerve Block		Not Receiving the Pudendal Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Receiving the Pudendal Nerve Block		Not Receiving the Pudendal Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/26 (0%)

Limitations/Caveats

The main limitation of the study was represented by the small number of enrolled patients and larger sample are required to confirm our results.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.