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Clinical Trials/NCT06769204
NCT06769204Not yet recruitingPhase 3

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

Cairo University0 sites90 target enrollmentStarted: February 10, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
90
Primary Endpoint
pain during Cervical instrumentation of the tenaculum and cannula
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

lidocaine prilocaine

Experimental

Intervention: EMLA SPRAY (Drug)

placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • pain At the end of uterine filling(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Samy aly ashour

professor

Cairo University

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