NCT03825016

Brief Summary

Lidocaine infusion in hystroscopic media versus oral diclofenac

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Aug 2017

Typical duration for phase_2 pain

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

August 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

January 30, 2019

Last Update Submit

January 26, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Degree of pain "measured by visual analogue scale"

    measured by visual analogue scale

    1 hour

Study Arms (2)

Lidocaine

EXPERIMENTAL

Lidocaine Hydrochloride

Drug: Lidocaine Hydrochloride

Diclofenac

EXPERIMENTAL

Oral Diclofenac

Drug: Diclofenac Sodium

Interventions

Lidocaine HydrochlorideDRUG

Lidocaine infusion on hystroscopic media during office hystroscopy

Lidocaine
Diclofenac SodiumDRUG

Oral Diclofenac Sodium

Diclofenac

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • BMI 18.5-30 kg/m2
  • Diagnostic hystroscope

You may not qualify if:

  • Previous cervical surgery
  • Cervical stenosis
  • PID
  • allergy to NSAID
  • Gastritis or peptic ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineDiclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

August 1, 2017

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)