NCT04505657

Brief Summary

our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

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

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

August 6, 2020

Last Update Submit

September 27, 2021

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during the procedure

    Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

    10 minuets

Study Arms (3)

Celecoxib plus lidocaine

EXPERIMENTAL

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure

Drug: celecoxib plus lidocaine

Celecoxib

ACTIVE COMPARATOR

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure

Drug: Celecoxib

lidocaine

ACTIVE COMPARATOR

placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure

Drug: lidocaine

Interventions

celecoxib plus lidocaineDRUG

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure

Also known as: experimental
Celecoxib plus lidocaine
CelecoxibDRUG

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure

Also known as: Active Comparator
Celecoxib
lidocaineDRUG

placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure

Also known as: Active Comparato
lidocaine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale request hystrosalpingogram
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • any patient came for Hysterosalpingography

You may not qualify if:

  • any patient has contraindication to Hysterosalpingography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

CelecoxibLidocaine

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAniline CompoundsAmines

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2021

Study Completion

September 27, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)