NCT03405922

Brief Summary

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

January 12, 2018

Last Update Submit

July 9, 2019

Conditions

Perianal FistulaFissure in AnoHemorrhoids

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced)

    24 hours post-surgery

Secondary Outcomes (1)

  • Quality of Life assessed by questionnaire

    2 weeks post-surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 40 mL Saline 0.9%

Drug: Placebo 40 mL Saline 0.9%

Ropivacain

ACTIVE COMPARATOR

40 mL Ropivacain 0.5%

Drug: 40 mL Ropivacain 0.5%

Interventions

Placebo 40 mL Saline 0.9%DRUG

Injection of 40 mL 0.9% saline

Placebo
40 mL Ropivacain 0.5%DRUG

Ropivacaine Hcl 0.5% Injection 40 mL

Ropivacain

Eligibility Criteria

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

You may qualify if:

  • Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
  • Age of 18 or above

You may not qualify if:

  • age under 18.
  • Patients unable to understand an informed consent.
  • Emergency operations
  • Pregnant women.
  • Patients with acute perianal infection.
  • Patients allergic to any component of the local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

Related Publications (1)

  • Rotigliano N, Fuglistaler I, Guenin MO, Dursunoglu GB, Freiermuth D, von Flue M, Steinemann DC. Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT). Br J Surg. 2020 Jul;107(8):960-969. doi: 10.1002/bjs.11520. Epub 2020 Mar 18.

    PMID: 32187663DERIVED

MeSH Terms

Conditions

Fissure in AnoHemorrhoids

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Daniel Steinemann

    St:Claraspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

February 1, 2018

Primary Completion

July 5, 2019

Study Completion

July 5, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)