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