Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief

NCT07383571 | Completed

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

Brief 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.

Conditions

Hysterosalpingography

Keywords

hysterosalpingography

Outcome Measures

Primary Outcomes (1)

• Pain during cervical instrumentation

  Pain intensity during cervical instrumentation, including tenaculum placement and cervical cannulation, measured using an 11-point numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable

  Within 1 minute after tenaculum placement and cervical cannulation, before contrast injection.

Secondary Outcomes (7)

• Pain after speculum insertion before cervical instrumentation

  Intra-procedure, immediately after speculum insertion and before cervical instrumentation.

• Pain 30 minutes after HSG

  30 minutes post-procedure

• Patient satisfaction 30 minutes after HSG

  30 minutes postprocedure

• Pain during uterine filling

  During HSG, at the end of uterine filling / immediately after contrast injection.

• Post-procedure rescue analgesia

  After the 30-minute post-procedure pain assessment.

Study Arms (3)

Oral Hyoscine butylbromide and Placebo Spray

EXPERIMENTAL

Participants received a single 20 mg oral tablet of hyoscine butylbromide 30 minutes before hysterosalpingography, together with placebo cervical spray applied 10 minutes before the procedure.

Drug: Oral Hyoscine butylbromide and Placebo Spray

Topical lidocaine-prilocaine spray and placebo oral tablet

ACTIVE COMPARATOR

Participants received topical lidocaine-prilocaine spray applied as three sprays to the ectocervix and external cervical os 10 minutes before hysterosalpingography, together with a placebo oral tablet given 30 minutes before the procedure.

Drug: Topical lidocaine-prilocaine spray and placebo oral tablet

Double Placebo

PLACEBO COMPARATOR

Participants received a placebo oral tablet 30 minutes before HSG and placebo cervical spray applied to the ectocervix and external cervical os 10 minutes before the procedure.

Drug: Double Placebo

Interventions

Oral Hyoscine butylbromide and Placebo Spray DRUG

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.

Oral Hyoscine butylbromide and Placebo Spray

Double Placebo DRUG

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.

Double Placebo

Topical lidocaine-prilocaine spray and placebo oral tablet DRUG

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.

Topical lidocaine-prilocaine spray and placebo oral tablet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 40 years
• Primary infertility
• Scheduled to undergo hysterosalpingography as part of routine infertility evaluation
• Regular menstrual cycles
• Hysterosalpingography scheduled during the early proliferative phase of the menstrual cycle, days 6 to 12
• Negative urine pregnancy test on the day of the procedure
• Able to understand and use the 0 to 10 Numerical Rating Scale for Pain assessment

You may not qualify if:

• Secondary infertility
• Known hypersensitivity to hyoscine, lidocaine, or prilocaine
• Use of systemic analgesics, sedatives, or antispasmodics within 24 hours before hysterosalpingography
• Chronic pelvic pain or severe dysmenorrhoea requiring regular analgesia
• Active pelvic infection
• Known uterine anomaly
• Cervical stenosis necessitating anaesthesia
• History of contrast allergy
• Inability to cooperate with numerical pain scoring
• Current pregnancy
• Severe systemic disease corresponding to American Society of Anesthesiologists physical status class III or higher

Sponsors & Collaborators

• Cairo University: lead
• Aljazeera Hospital: collaborator

Study Sites (1)

Algezeera Hospital

Giza, Egypt

Location

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

  Algezeera Hospital

  PRINCIPAL INVESTIGATOR

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: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)