Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
ConditionHysterosalpingography-Related Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBalikesir University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Indomethacin 100Mg Suppository
DrugA 100 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.
Lidocaine %2 ampoule
DrugA 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: No PremedicationNo intervention 0 interventions
Group B: Rectal IndomethacinActive comparator 1 intervention
Group C: Paracervical Block With LidocaineActive comparator 1 intervention
Trial outcomes
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.
Time frame
During HSG, immediately after contrast-medium injectionSecondary outcomes
1
Pain Intensity During 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.
Time frame
During HSG, immediately after speculum insertion2
Correlation Between Preprocedural State Anxiety and Pain During 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.
Time frame
On the day of HSG, from the pre-randomization assessment through contrast injection.3
Pain Intensity During 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.
Time frame
During HSG, immediately after tenaculum application or cervical grasping4
Participant Satisfaction With Pain Control
Participant-reported satisfaction with pain control measured using a 0-to-10 scale, with higher scores indicating greater satisfaction.
Time frame
30 minutes after completion of HSGLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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