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

NCT07383571 | Recruiting

• 1 other identifier: HSG-Analgesia-2025
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hysterosalpingography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Baseline pain after speculum insertion

  INTRAPROCEDURE

• pain 30 minutes post procedure

  30 minutes post-procedure

• women satisfaction

  30 minutes postprocedure

Study Arms (3)

Oral Hyoscine butylbromide and Placebo Spray

EXPERIMENTAL

Drug: Oral Hyoscine butylbromide and Placebo Spray

Topical EMLA Spray and Placebo Oral Tablet

ACTIVE COMPARATOR

Drug: Topical EMLA Spray and Placebo Oral Tablet

Double Placebo

PLACEBO COMPARATOR

Other: Double Placebo

Interventions

Oral Hyoscine butylbromide and Placebo Spray DRUG

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

Oral Hyoscine butylbromide and Placebo Spray

Topical EMLA Spray and Placebo Oral Tablet DRUG

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

Topical EMLA Spray and Placebo Oral Tablet

Double Placebo OTHER

oral placebo tablet plus placebo cervical spray

Double Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing HSG for infertility evaluation
• Regular cycles; procedure scheduled in proliferative phase (days 6-12)
• Negative urine pregnancy test on procedure day

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Aljazeera Hospital: collaborator

Study Sites (1)

Al Gezeera Hospital

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Mahmoud Alalfy, MD

  Algazeera Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud alalfy, MD

CONTACT

+201002611058; mahmoudalalfy@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: February 3, 2026
• Study Start: October 3, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)