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Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief
Sponsor: Cairo University
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.
Official title: Oral Hyoscine Butylbromide Versus Topical Lidocaine-Prilocaine Spray Versus Placebo for Pain Relief During Hysterosalpingography: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-10-03
Completion Date
2026-04-30
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (1)
Algezeera Hospital
Giza, Egypt