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NOT YET RECRUITING
NCT07792668
PHASE4

Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

Sponsor: Balikesir University

View on ClinicalTrials.gov

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.

Official title: Comparison of No Premedication, Rectal Indomethacin Suppository, and Paracervical Block for Pain Reduction During Hysterosalpingography: A Prospective Randomized Three-Arm Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-11-01

Completion Date

2027-11-01

Last Updated

2026-10-01

Healthy Volunteers

Yes

Interventions

DRUG

Indomethacin 100Mg Suppository

A 100 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.

DRUG

Lidocaine %2 ampoule

A paracervical block will be performed using 2% lidocaine. Five milliliters of 2% lidocaine will be administered at the 4 o'clock position and 5 mL at the 8 o'clock position of the cervix, for a total volume of 10 mL and a total lidocaine dose of 200 mg. Injection depth will be approximately 1.5 to 3 cm. Hysterosalpingography will begin 5 minutes after completion of the paracervical block.