NCT04251884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 5, 2020

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

January 30, 2020

Results QC Date

May 2, 2020

Last Update Submit

March 1, 2022

Conditions

HemorrhoidsPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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"

    at 24 hours after the hemorrhoidectomy

Secondary Outcomes (5)

  • Postoperative Pain on the Visual Analogue Scale (VAS)

    at 6, 12 and 48 hours after the operation

  • Opioids Consumption

    Within 48 hours

  • Lenght of Hospital Stay

    up to 2 weeks

  • Complications Related to the Pudendal Nerve Block

    Within 6 weeks

  • Direct and Indirect Cost Analysis in Out- and In-patients

    Within the hospital stay

Study Arms (2)

Receiving the pudendal nerve block

EXPERIMENTAL
Procedure: Local anesthetic (ropivacaine)

Not receiving the pudendal nerve block

ACTIVE COMPARATOR
Procedure: Local anesthetic (ropivacaine)

Interventions

Local anesthetic (ropivacaine)PROCEDURE

Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block

Also known as: No pudendal nerve block
Not receiving the pudendal nerve blockReceiving the pudendal nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years old
  • Pregnancy
  • Allergy to local anaesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 32474710DERIVED

MeSH Terms

Conditions

HemorrhoidsPain, Postoperative

Interventions

Anesthetics, LocalRopivacaine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and 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.

Results Point of Contact

Title
Dr. Francesco Mongelli
Organization
Ospedale Regionale di Lugano
francesco.mongelli@mail.com
+41764706297

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

January 1, 2018

Primary Completion

December 29, 2019

Study Completion

January 30, 2020

Last Updated

March 11, 2022

Results First Posted

June 5, 2020

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)