Hysterosalpingography-Related Pain, Infertility
Conditions
Keywords
Hysterosalpingography, Procedural Pain, Indomethacin, Paracervical Block, Lidocaine, Infertility
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.
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.
Interventions
A 50 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.
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
Balikesir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale | During HSG, immediately after contrast-medium injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Speculum Insertion | During HSG, immediately after speculum insertion | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Pain Intensity During Cervical Grasping | During HSG, immediately after tenaculum application or cervical grasping | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Pain Intensity During Cannula or Catheter Placement | During HSG, immediately after cannula or catheter placement | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Pain Intensity During Cervical Traction | During HSG, immediately after cervical traction | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Immediate Post-Procedural Pain Intensity | Within 5 minutes after completion of HSG | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Pain Intensity 30 Minutes After HSG | 30 minutes after completion of HSG | Pain intensity measured using an 11-point NRS ranging from 0 to 10. |
| Preprocedural State Anxiety | After informed consent and before randomization and administration of the study intervention | 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. |
| Anticipated HSG Pain | Before randomization and administration of the study intervention. | Expected pain during HSG measured using a single 0-to-10 Numeric Rating Scale. |
| Participant Satisfaction With Pain Control | Immediately after HSG. | Participant-reported satisfaction with pain control measured using a 0-to-10 scale, with higher scores indicating greater satisfaction. |
| Requirement for Rescue Analgesia | From completion of HSG through 30 minutes after the procedure | Number/percentage requiring additional analgesia. |
| Participants With Adverse Events | From administration of the study intervention through 30 minutes after HSG | Nausea, vomiting, dizziness, vasovagal symptoms, allergic symptoms, rectal discomfort, injection-site bleeding/hematoma, severe cramping, etc. |
| Most Painful Procedural Step | Immediately after HSG | Participant-reported most painful step during HSG. |
Contacts
CONTACTSıla E DEMİRCAN, MD
PRINCIPAL_INVESTIGATORselim afşar, MD
Balikesir University
Outcome results
None listed