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

Cairo University102 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

102

Conditions

Hysterosalpingography

Interventions

Oral Hyoscine butylbromide and Placebo SprayDRUG

Hyoscine butylbromide 20 mg oral tablet, single dose 30 min before HSG PLUS placebo cervical spray

Topical EMLA Spray and Placebo Oral TabletDRUG

EMLA spray (lidocaine 2.5% + prilocaine 2.5%), 3 sprays to ectocervix/external os, 10 min before HSG plus placebo oral tablet

Double PlaceboOTHER

oral placebo tablet plus placebo cervical spray

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Al Gezeera Hospital

Giza, Egypt

RECRUITING

Outcomes

Primary Outcomes

Pain intensity (VAS) during cervical instrumentation (after tenaculum and cannula placement)

Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame: IMMEDIATE(1 MINUTE)

Pain at end of uterine filling

"Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame: INTRA-PROCEDURE

Secondary Outcomes

Baseline pain after speculum insertion

"Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame: INTRAPROCEDURE

pain 30 minutes post procedure

"Pain will be measured using a 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame: 30 minutes post-procedure

women satisfaction

it will be measured using a 0-10 Numerical Rating Scale (NRS) like scale , where 0 indicates no satisfaction and 10 indicates the maximum satisfaction

Time frame: 30 minutes postprocedure

Central Contacts

Mahmoud alalfy, MD

CONTACT

+201002611058 mahmoudalalfy@ymail.com

Data from ClinicalTrials.gov

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