Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

NCT07792668 | Not Yet Recruiting Phase 3

• 1 other identifier: HSG-PAIN-001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Hysterosalpingography-Related Pain; Infertility

Keywords

Hysterosalpingography; Procedural Pain; Indomethacin; Paracervical Block; Lidocaine; Infertility

Outcome Measures

Primary Outcomes (1)

• Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale

  Participant-reported pain intensity will be measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

  During HSG, immediately after contrast-medium injection

Secondary Outcomes (12)

• Pain Intensity During Speculum Insertion

  During HSG, immediately after speculum insertion

• Pain Intensity During Cervical Grasping

  During HSG, immediately after tenaculum application or cervical grasping

• Pain Intensity During Cannula or Catheter Placement

  During HSG, immediately after cannula or catheter placement

• Pain Intensity During Cervical Traction

  During HSG, immediately after cervical traction

• Immediate Post-Procedural Pain Intensity

  Within 5 minutes after completion of HSG

Study Arms (3)

No Premedication

NO INTERVENTION

Participants will undergo standard hysterosalpingography without analgesic or local anesthetic premedication.

Rectal Indomethacin

ACTIVE COMPARATOR

A 50 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.

Drug: Indomethacin 25 MG/50 MG

Paracervical Block With Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocaine %2 ampoule

Interventions

Indomethacin 25 MG/50 MG DRUG

A 50 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.

Rectal Indomethacin

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.

Paracervical Block With Lidocaine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18 to 45 years
• Scheduled for diagnostic hysterosalpingography as part of infertility evaluation
• Able to understand the study procedures and provide written informed consent
• Able to report pain intensity using a 0-to-10 Numeric Rating Scale
• Hysterosalpingography scheduled during the appropriate menstrual-cycle period according to routine institutional practice
• Pregnancy excluded before hysterosalpingography according to routine institutional practice

You may not qualify if:

• Pregnancy or suspected pregnancy
• Active pelvic inflammatory disease or active genital tract infection
• Known hypersensitivity or contraindication to indomethacin or other nonsteroidal anti-inflammatory drugs
• Known hypersensitivity to lidocaine or other amide-type local anesthetics
• Known hypersensitivity to the contrast medium used for hysterosalpingography
• Active peptic ulcer disease or a history of clinically significant gastrointestinal bleeding
• Significant renal or hepatic disease
• Clinically significant bleeding disorder
• Current anticoagulant therapy
• Use of systemic analgesic, sedative, or antispasmodic medication within the predefined period before hysterosalpingography
• Chronic pelvic pain requiring regular analgesic treatment
• Severe dysmenorrhea requiring regular analgesic treatment
• Cervical stenosis requiring anesthesia for hysterosalpingography Inability to provide reliable pain scores

Sponsors & Collaborators

• Balikesir University: lead

MeSH Terms

Conditions

Infertility; Pain, Procedural

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• selim afşar, MD

  Balikesir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sıla E DEMİRCAN, MD

CONTACT

+905301540874; silademircan2008@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OB/GYN resident

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08