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Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief

NCT07383571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-06-11

No results posted yet for this study

Summary

This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.

Conditions

  • Hysterosalpingography

Interventions

DRUG

Oral Hyoscine butylbromide and Placebo Spray

Hyoscine butylbromide 20 mg oral tablet, single dose, administered 30 minutes before HSG, plus placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before HSG.

DRUG

Topical lidocaine-prilocaine spray and placebo oral tablet

Topical lidocaine-prilocaine spray, Manovipercaine Plus, EVA Pharma, Egypt, containing lidocaine 15% and prilocaine 5%, applied as three sprays to the ectocervix and external cervical os 10 minutes before HSG, plus placebo oral tablet administered 30 minutes before HSG.

DRUG

Double Placebo

Placebo oral tablet administered 30 minutes before HSG plus placebo cervical spray applied 10 minutes before HSG, at the same time points as the active interventions.

Sponsors & Collaborators

  • Aljazeera Hospital

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Mahmoud Alalfy, MD · Algezeera Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2026-04-01
Completion
2026-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07383571 on ClinicalTrials.gov