Oral hyoscine or topical EMLA to reduce pain 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 will test whether taking oral hyoscine or using a topical EMLA spray reduces pain for women undergoing hysterosalpingography.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT07383571 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled, three-arm trial compares oral hyoscine butylbromide, topical eutectic lidocaine-prilocaine (EMLA) spray, and placebo for pain relief during hysterosalpingography in women evaluated for infertility. Participants are randomized to one of the three arms and receive active treatment plus matching placebo to maintain blinding. Pain during the procedure is recorded using a visual analogue scale (VAS) and procedural data are collected. Key eligibility includes regular menstrual cycles with the procedure scheduled in the proliferative phase and a negative pregnancy test, while exclusions include drug allergies, recent analgesic use, active pelvic infection, or uterine/cervical conditions requiring anesthesia.
Who should consider this trial
Good fit: Women undergoing HSG for infertility with regular cycles, a procedure scheduled in the proliferative phase, a negative pregnancy test, and no contraindicating allergies or recent medications are ideal candidates.
Not a fit: Patients with chronic pelvic pain or severe dysmenorrhea, active pelvic infection, uterine anomalies or cervical stenosis requiring anesthesia, recent use of systemic analgesics/antispasmodics, or known hypersensitivity to hyoscine, lidocaine, or prilocaine are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, these simple, low-cost treatments could lower pain during HSG and make the procedure more tolerable for patients.
How similar studies have performed: Prior small trials of topical anesthetics and antispasmodics for HSG have shown mixed but sometimes modest pain reductions, so existing evidence is limited and inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Giza
- Al Gezeera Hospital — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Mahmoud Alalfy, MD — Algazeera Hospital
- Study coordinator: Mahmoud alalfy, MD
- Email: mahmoudalalfy@ymail.com
- Phone: +201002611058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.