Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

Sponsor
Balikesir University
Study ID
NCT07792668
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Hysterosalpingography-Related Pain
  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Indomethacin 25 MG/50 MG — DRUG
    A 50 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.
  • Lidocaine %2 ampoule — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: No Premedication
    Participants will undergo standard hysterosalpingography without analgesic or local anesthetic premedication.
  • Active Comparator: Rectal Indomethacin
    A 50 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.
  • Active Comparator: Paracervical Block With Lidocaine
    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.

Primary Outcome Measure

Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale [ Time Frame: During HSG, immediately after contrast-medium injection ]

Central Contacts

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