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

Safety and Efficacy of Oral Hyoscine Butylbromide Versus Topical EMLA Spray in Reducing Pain During Hysterosalpingography: A Randomized Double-Blind Placebo-Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Hysterosalpingography
• Intervention / Treatment: Drug: Oral Hyoscine butylbromide and Placebo Spray; Drug: Topical EMLA Spray and Placebo Oral Tablet; Other: Double Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud alalfy, MD; Phone Number: +201002611058; Email: mahmoudalalfy@ymail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Al Gezeera Hospital
    • Contact: mahmoud Alalfy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Hyoscine butylbromide and Placebo Spray	Drug: Oral Hyoscine butylbromide and Placebo Spray; Hyoscine butylbromide 20 mg oral tablet, single dose 30 min before HSG PLUS placebo cervical spray
Active Comparator: Topical EMLA Spray and Placebo Oral Tablet	Drug: Topical EMLA Spray and Placebo Oral Tablet; EMLA spray (lidocaine 2.5% + prilocaine 2.5%), 3 sprays to ectocervix/external os, 10 min before HSG plus placebo oral tablet
Placebo Comparator: Double Placebo	Other: Double Placebo; oral placebo tablet plus placebo cervical spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	INTRA-PROCEDURE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	30 minutes postprocedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Aljazeera Hospital
• Investigators: Principal Investigator: Mahmoud Alalfy, MD, Algazeera Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Alkaloids; Amines; Aza Compounds; Quaternary Ammonium Compounds; Heterocyclic Compounds, Bridged-Ring; Tropanes; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Scopolamine Derivatives; Butylscopolammonium Bromide
• Other Study ID Numbers: HSG-Analgesia-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No