Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

January 7, 2025 updated by: Ahmed Samy aly ashour, Cairo University

Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria:

  • Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.
  • Current pregnancy or suspicion of pregnancy.
  • Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
  • Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure
Experimental: lidocaine prilocaine
Drug: EMLA SPRAY
2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure
Other Names:
  • 2 puffs into

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during Cervical instrumentation of the tenaculum and cannula
Time Frame: 1 minute
pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain At the end of uterine filling
Time Frame: 5 minutes
pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP SPRAY HSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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