Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

Phase 3Not Yet RecruitingNCT07792668

Balikesir University180 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Interventions

Indomethacin 25 MG/50 MGDRUG

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

Lidocaine %2 ampouleDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: During HSG, immediately after contrast-medium injection