Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial (HSG-PAIN)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; Hysterosalpingography-Related Pain
• Intervention / Treatment: Drug: Indomethacin 25 MG/50 MG; Drug: Lidocaine %2 ampoule

Detailed Description

Hysterosalpingography is an established diagnostic procedure used to assess tubal patency and uterine cavity morphology during infertility evaluation. Pain may occur at several procedural stages, including speculum insertion, cervical grasping, cannula placement, cervical traction, uterine distension, and contrast-medium injection.

This study is designed as a prospective, randomized, parallel-group, three-arm controlled superiority trial. Participants will be allocated in a 1:1:1 ratio to no premedication, rectal indomethacin, or paracervical block with lidocaine.

Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The primary outcome is pain during contrast-medium injection. Additional procedural pain scores, immediate post-procedural pain, pain at 30 minutes, preprocedural anxiety, anticipated pain, participant satisfaction, requirement for rescue analgesia, and adverse events will also be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sıla E DEMİRCAN, MD; Phone Number: +905301540874; Email: silademircan2008@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Indomethacin 25 MG/50 MG; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity During Speculum Insertion	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	During HSG, immediately after speculum insertion
Pain Intensity During Cervical Grasping	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	During HSG, immediately after tenaculum application or cervical grasping
Pain Intensity During Cannula or Catheter Placement	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	During HSG, immediately after cannula or catheter placement
Pain Intensity During Cervical Traction	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	During HSG, immediately after cervical traction
Immediate Post-Procedural Pain Intensity	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	Within 5 minutes after completion of HSG
Pain Intensity 30 Minutes After HSG	Pain intensity measured using an 11-point NRS ranging from 0 to 10.	30 minutes after completion of HSG
Preprocedural State Anxiety	Preprocedural state anxiety measured using the validated Turkish five-item short version of the State Anxiety Inventory (STAIS-5). Higher scores indicate greater state anxiety.	After informed consent and before randomization and administration of the study intervention
Anticipated HSG Pain	Expected pain during HSG measured using a single 0-to-10 Numeric Rating Scale.	Before randomization and administration of the study intervention.
Participant Satisfaction With Pain Control	Participant-reported satisfaction with pain control measured using a 0-to-10 scale, with higher scores indicating greater satisfaction.	Immediately after HSG.
Requirement for Rescue Analgesia	Number/percentage requiring additional analgesia.	From completion of HSG through 30 minutes after the procedure
Participants With Adverse Events	Nausea, vomiting, dizziness, vasovagal symptoms, allergic symptoms, rectal discomfort, injection-site bleeding/hematoma, severe cramping, etc.	From administration of the study intervention through 30 minutes after HSG
Most Painful Procedural Step	Participant-reported most painful step during HSG.	Immediately after HSG

Collaborators and Investigators

• Sponsor: Balikesir University
• Investigators: Principal Investigator: selim afşar, MD, Balikesir University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; Lidocaine; Indomethacin; Paracervical Block; Hysterosalpingography; Procedural Pain
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Infertility; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indomethacin
• Other Study ID Numbers: HSG-PAIN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No