Oral Hyoscine vs. Topical EMLA vs. Placebo for Pain Reduction During Hysterosalpingography

Cairo University (CU)

Status: Enrolling

Conditions: Hysterosalpingography

Treatments: Drug: Topical EMLA Spray and Placebo Oral Tablet; Drug: Oral Hyoscine butylbromide and Placebo Spray; Other: Double Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07383571

HSG-Analgesia-2025

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, will evaluate whether oral hyoscine butylbromide or topical eutectic lidocaine-prilocaine (EMLA) spray reduces pain during hysterosalpingography (HSG) compared with placebo

Full description

This randomized, double-blind, placebo-controlled, three-arm clinical trial will evaluate whether oral hyoscine butylbromide or topical eutectic lidocaine-prilocaine (EMLA) spray reduces pain during hysterosalpingography (HSG) compared with placebo

Enrollment: 102 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing HSG for infertility evaluation

Regular cycles; procedure scheduled in proliferative phase (days 6-12)

Negative urine pregnancy test on procedure day

Exclusion criteria

• Known hypersensitivity to hyoscine, lidocaine, prilocaine.

Use of systemic analgesics, sedatives, or antispasmodics within 24 hrs pre-HSG

Chronic pelvic pain or severe dysmenorrhea requiring regular analgesics

Active pelvic infection, uterine anomaly, cervical stenosis requiring anesthesia

History of contrast allergy

Inability to cooperate with VAS reporting

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

Oral Hyoscine butylbromide and Placebo Spray

Experimental group

Treatment:

Drug: Oral Hyoscine butylbromide and Placebo Spray

Topical EMLA Spray and Placebo Oral Tablet

Active Comparator group

Treatment:

Drug: Topical EMLA Spray and Placebo Oral Tablet

Double Placebo

Placebo Comparator group

Treatment:

Other: Double Placebo