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Not Yet Recruiting NCT07792668

Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

Conditions: Hysterosalpingography-Related Pain

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 180
Sponsor: Balikesir University

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.

Eligibility Criteria

Inclusion Criteria: * Female patients aged 18-45 years. * Scheduled for diagnostic hysterosalpingography (HSG) as part of infertility evaluation. * Able to understand the study and provide written informed consent. * Able to report pain using a 0-10 Numeric Rating Scale (NRS). * HSG scheduled within the appropriate menstrual-cycle window according to the local clinical protocol. * Pregnancy excluded according to the local clinical protocol. Exclusion Criteria: * Pregnancy or suspected pregnancy. * Active pelvic inflammatory disease or active genital tract infection. * Known allergy or contraindication to indomethacin, nonsteroidal anti-inflammatory drugs (NSAIDs), lidocaine, or amide-type local anesthetics. * Known contrast-media allergy. * Active peptic ulcer disease or a significant history of gastrointestinal bleeding. * Significant renal, hepatic, or cardiovascular disease; a bleeding disorder; or current anticoagulant therapy. * Use of systemic analgesics, sedatives, or antispasmodics within the protocol-defined pre-HSG window. * Chronic pelvic pain or severe dysmenorrhea requiring regular analgesic treatment. * Cervical stenosis requiring anesthesia or anticipated difficult cannulation. * Inability to provide reliable pain scores or refusal to participate.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07792668). StuddyBuddy aggregates publicly available trial information.