drugset / Trial / NCT07792668

Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

NCT07792668 ↗

Phase 4 Not yet recruiting 180 enrolled Balikesir University
RandomizedParallel-groupOpen-labelSupportive care

Summary

Hysterosalpingography (HSG) is commonly performed during infertility evaluation and may cause pain during cervical manipulation, uterine distension, and contrast-medium injection. This prospective, randomized, three-arm controlled trial will compare three pain-control approaches during HSG: no analgesic premedication, rectal indomethacin administered before the procedure, and paracervical block with lidocaine. Eligible women scheduled for diagnostic HSG will be randomized in a 1:1:1 ratio. The primary outcome will be participant-reported pain during contrast-medium injection measured using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10. Secondary outcomes will include pain during other procedural stages, immediate and 30-minute post-procedural pain, preprocedural anxiety, anticipated pain, rescue analgesic requirement, participant satisfaction, and adverse events.

Timeline

Start
2026-11-01
Primary completion
2027-06-01
Completion
2027-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Indomethacin Small molecule 100 mg Rectal
Comparator Lidocaine Other / unclassified 200 mg Other

Indications

No indication recorded.