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Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

NCT07792668 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Indomethacin 25 MG/50 MG

A 50 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.

Sponsors & Collaborators

  • Balikesir University

    lead OTHER

Principal Investigators

  • selim afşar, MD · Balikesir University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-06-01
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792668 on ClinicalTrials.gov