Hysterosalpingography-Related Pain
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 a commonly used diagnostic procedure in the evaluation of infertility and may cause pain during cervical manipulation, cannula or catheter placement, cervical traction, uterine distension, and contrast injection. Participants will be randomized in a 1:1:1 ratio to one of three groups: no analgesic premedication; a single 100 mg rectal indomethacin suppository administered 30 minutes before HSG; or paracervical block with 2% lidocaine hydrochloride administered at the 4 and 8 o'clock positions of the cervix. The total lidocaine dose will not exceed 4.5 mg/kg or 200 mg, whichever is lower, and HSG will begin approximately 5 minutes after completion of the block. Pain will be assessed using a 0-10 Numeric Rating Scale at predefined procedural time points. The primary endpoint is pain during contrast injection. Additional assessments include baseline pain, pain during speculum placement, cervical manipulation, cannula or catheter placement and cervical traction, immediate post-procedure pain, pain 30 minutes after HSG, rescue analgesia requirement, participant satisfaction, vasovagal symptoms, adverse events, and the most painful procedural step. Before randomization, participants will also complete the Turkish five-item short form of the State-Trait Anxiety Inventory (STAIS-5) and rate their expected HSG pain on a 0-10 scale.
Interventions
A 100 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
NONE
Masking description
This is an open-label study. Participants and investigators are aware of the assigned intervention. Treatment groups will be coded during statistical analysis to minimize identification of the intervention groups where feasible.
Intervention model description
Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: no analgesic premedication, rectal indomethacin, or paracervical block with lidocaine.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients aged 18-45 years. * Scheduled for diagnostic hysterosalpingography (HSG) as part of infertility evaluation. * Able to understand the study and provide written informed consent. * Able to report pain using a 0-10 Numeric Rating Scale (NRS). * HSG scheduled within the appropriate menstrual-cycle window according to the local clinical protocol. * Pregnancy excluded according to the local clinical protocol.
Exclusion criteria
* Pregnancy or suspected pregnancy. * Active pelvic inflammatory disease or active genital tract infection. * Known allergy or contraindication to indomethacin, nonsteroidal anti-inflammatory drugs (NSAIDs), lidocaine, or amide-type local anesthetics. * Known contrast-media allergy. * Active peptic ulcer disease or a significant history of gastrointestinal bleeding. * Significant renal, hepatic, or cardiovascular disease; a bleeding disorder; or current anticoagulant therapy. * Use of systemic analgesics, sedatives, or antispasmodics within the protocol-defined pre-HSG window. * Chronic pelvic pain or severe dysmenorrhea requiring regular analgesic treatment. * Cervical stenosis requiring anesthesia or anticipated difficult cannulation. * Inability to provide reliable pain scores or refusal to participate.
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 | Participant-reported pain intensity will be measured using an 11-point Numeric Rating Scale (NRS), with scores ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. |
| Correlation Between Preprocedural State Anxiety and Pain During Contrast Injection | On the day of HSG, from the pre-randomization assessment through contrast injection. | The correlation between preprocedural state anxiety, measured using the Turkish five-item State Anxiety Inventory Short Form (STAIS-5), and pain during contrast injection, measured using a 0-10 Numeric Rating Scale (NRS), will be evaluated using Pearson or Spearman correlation. A single correlation coefficient ranging from -1 to +1 will be reported. |
| Pain Intensity During Cervical Grasping | During HSG, immediately after tenaculum application or cervical grasping | Participant-reported pain intensity will be measured using an 11-point Numeric Rating Scale (NRS), with scores ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. |
| Participant Satisfaction With Pain Control | 30 minutes after completion of HSG | Participant-reported satisfaction with pain control measured using a 0-to-10 scale, with higher scores indicating greater satisfaction. |
| Pain Intensity During Cannula or Catheter Placement | During HSG, immediately after cannula or catheter placement | Participant-reported pain intensity will be measured using an 11-point Numeric Rating Scale (NRS), with scores ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst imaginable pain. |
| 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. |
| Correlation Between Expected HSG Pain and Pain During Contrast İnjection | On the day HSG, from the pre-randomization assessment to contrast injection | Expected pain before hsg and actual pain during contrast injection will be assessed using a 0-10 nrs. The relationship between these two scores will be valuated using pearson or spearman correlation. The result will be reported as a single correlation coefficient ranging from -1 to +1 |
| 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