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

Oral Hyoscine Butylbromide Versus Topical Lidocaine-Prilocaine Spray Versus Placebo for Pain Relief During Hysterosalpingography: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial

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.

This was a single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial conducted at the Department of Obstetrics and Gynaecology, Al Gezeera Hospital, Giza, Egypt. Women aged 18-40 years with primary infertility scheduled for hysterosalpingography during the early proliferative phase of the menstrual cycle were randomly assigned in a 1:1:1 ratio to receive oral hyoscine butylbromide 20 mg with placebo cervical spray, topical lidocaine-prilocaine spray with placebo oral tablet, or double placebo. A double-dummy technique was used to preserve blinding across oral and topical routes of administration. Pain was assessed using a 0-10 numerical rating scale at predefined procedural time points. The primary outcome was pain during cervical instrumentation. Secondary outcomes included pain during uterine filling, pain after speculum insertion, pain 30 minutes after the procedure, patient satisfaction, rescue analgesia and adverse events.Before recruitment and randomisation of the first participant, the protocol was amended and approved by the Research Ethics Committee to specify the topical lidocaine-prilocaine spray formulation and the final outcome hierarchy described below. The registry record was subsequently updated during final study-data updating to reflect the approved amended protocol.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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