Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography

NCT ID: NCT04505657

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-27

Brief Summary

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

Detailed Description

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hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Conditions

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
randomized controlled trial

Study Groups

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Celecoxib plus lidocaine

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

Group Type EXPERIMENTAL

celecoxib plus lidocaine

Intervention Type DRUG

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

Celecoxib

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

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

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

lidocaine

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

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

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

Interventions

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celecoxib plus lidocaine

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

Intervention Type DRUG

Celecoxib

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

Intervention Type DRUG

lidocaine

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

Intervention Type DRUG

Other Intervention Names

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experimental Active Comparator Active Comparato

Eligibility Criteria

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Inclusion Criteria

* any patient came for Hysterosalpingography

Exclusion Criteria

* any patient has contraindication to Hysterosalpingography
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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aswu/351/5/19

Identifier Type: -

Identifier Source: org_study_id

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