Back to resultsPudendal Nerve Block for Hemorrhoidectomy
Primary Purpose
Hemorrhoids, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Local anesthetic (ropivacaine)
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility Criteria
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
Sites / Locations
- Ospedale Regionale di Bellinzona e Valli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Receiving the pudendal nerve block
Not receiving the pudendal nerve block
Arm Description
Outcomes
Primary Outcome Measures
Postoperative Pain on the Visual Analogue Scale (VAS)
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
Postoperative Pain on the Visual Analogue Scale (VAS)
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is "no pain at all" and 10 is "the strongest pain"
Opioids Consumption
Lenght of Hospital Stay
Complications Related to the Pudendal Nerve Block
Direct and Indirect Cost Analysis in Out- and In-patients
Ongoing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04251884
Brief Title
Pudendal Nerve Block for Hemorrhoidectomy
Official Title
Pudendal Nerve Block in Patient Treated for Hemorrhoidectomy Under Spinal Anaesthesia: Prospective Randomized Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 29, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francesco Mongelli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receiving the pudendal nerve block
Arm Type
Experimental
Arm Title
Not receiving the pudendal nerve block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic (ropivacaine)
Other Intervention Name(s)
No pudendal nerve block
Intervention Description
Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Title
Opioids Consumption
Time Frame
Within 48 hours
Title
Lenght of Hospital Stay
Time Frame
up to 2 weeks
Title
Complications Related to the Pudendal Nerve Block
Time Frame
Within 6 weeks
Title
Direct and Indirect Cost Analysis in Out- and In-patients
Description
Ongoing
Time Frame
Within the hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ospedale Regionale di Bellinzona e Valli
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32474710
Citation
Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.
Results Reference
derived
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Pudendal Nerve Block for Hemorrhoidectomy
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