Hysterosalpingography-Related PainPhase 4HSG-PAINNCT07792668
Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
A Phase 4 study testing Indomethacin 100Mg Suppository and Lidocaine %2 ampoule in people with Hysterosalpingography-Related Pain, run by Balikesir University.
Trial summary
Hysterosalpingography (HSG) is commonly performed during infertility evaluation and may cause pain during cervical manipulation, uterine distension, and contrast-medium injection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterosalpingography-Related Pain
- What is being tested?
- Indomethacin 100Mg Suppository and Lidocaine %2 ampoule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hysterosalpingography-Related Pain
- Being tested
- Indomethacin 100Mg Suppository, Lidocaine %2 ampoule
- Keywords
- Hysterosalpingography, Procedural Pain, Indomethacin, Paracervical Block, Lidocaine, Infertility
- Medical subject headings
- Pain, Procedural, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin 100Mg SuppositoryDrug
A 100 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.
| Study group | Role | What they receive |
|---|---|---|
| No Premedication | No intervention | Participants will undergo standard hysterosalpingography without analgesic or local anesthetic premedication. |
| Rectal Indomethacin | Active comparator | Participants will receive a single 100 mg rectal indomethacin suppository 30 minutes before hysterosalpingography. Receives: Drug: Indomethacin 100Mg Suppository |
| Paracervical Block With Lidocaine | Active comparator | 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. Receives: Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During HSG, immediately after contrast-medium injection
Secondary outcomes (12)
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.
Measured: During HSG, immediately after speculum insertion
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.
Measured: On the day of HSG, from the pre-randomization assessment through contrast injection.
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.
Measured: During HSG, immediately after tenaculum application or cervical grasping
Participant Satisfaction With Pain Control
Participant-reported satisfaction with pain control measured using a 0-to-10 scale, with higher scores indicating greater satisfaction.
Measured: 30 minutes after completion of HSG
Pain Intensity During 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.
Measured: 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.
Measured: During HSG, immediately after cervical traction
Immediate Post-Procedural Pain Intensity
Pain intensity measured using an 11-point NRS ranging from 0 to 10.
Measured: 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.
Measured: 30 minutes after completion of HSG
Correlation Between Expected HSG Pain and Pain During Contrast İnjection
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
Measured: On the day HSG, from the pre-randomization assessment to contrast injection
Requirement for Rescue Analgesia
Number/percentage requiring additional analgesia.
Measured: 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.
Measured: From administration of the study intervention through 30 minutes after HSG
Most Painful Procedural Step
Participant-reported most painful step during HSG.
Measured: Immediately after HSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterosalpingography-Related PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Sila Demircan, Balikesir University
- Investigators
- selim afşar, MD, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792668
- Sponsor's protocol ID
- HSG-PAIN-001
- Acronym
- HSG-PAIN
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of No Premedication, Rectal Indomethacin Suppository, and Paracervical Block for Pain Reduction During Hysterosalpingography: A Prospective Randomized Three-Arm Controlled Trial
- ClinicalTrials.gov ID
- NCT07792668
- Acronym / sponsor ID
- HSG-PAIN / HSG-PAIN-001
- Conditions
- Hysterosalpingography-Related Pain
- Keywords
- Hysterosalpingography, Procedural Pain, Indomethacin, Paracervical Block, Lidocaine, Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| No Premedication | No intervention | –Participants will undergo standard hysterosalpingography without analgesic or local anesthetic premedication. |
| Rectal Indomethacin | Active comparator | Drug: Indomethacin 100Mg SuppositoryParticipants will receive a single 100 mg rectal indomethacin suppository 30 minutes before hysterosalpingography. |
| Paracervical Block With Lidocaine | Active comparator | Drug: Lidocaine %2 ampouleA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin 100Mg SuppositoryA 100 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography. | Drug | Rectal Indomethacin |
| Lidocaine %2 ampouleA 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 | Paracervical Block With Lidocaine |
Primary outcome
Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale
Time frame: 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.
12 secondary outcomes
Pain Intensity During Speculum Insertion
Time frame: During HSG, immediately after speculum insertion
Correlation Between Preprocedural State Anxiety and Pain During Contrast Injection
Time frame: On the day of HSG, from the pre-randomization assessment through contrast injection.
Pain Intensity During Cervical Grasping
Time frame: During HSG, immediately after tenaculum application or cervical grasping
Participant Satisfaction With Pain Control
Time frame: 30 minutes after completion of HSG
Pain Intensity During Cannula or Catheter Placement
Time frame: During HSG, immediately after cannula or catheter placement
Pain Intensity During Cervical Traction
Time frame: During HSG, immediately after cervical traction
Immediate Post-Procedural Pain Intensity
Time frame: Within 5 minutes after completion of HSG
Pain Intensity 30 Minutes After HSG
Time frame: 30 minutes after completion of HSG
Correlation Between Expected HSG Pain and Pain During Contrast İnjection
Time frame: On the day HSG, from the pre-randomization assessment to contrast injection
Requirement for Rescue Analgesia
Time frame: From completion of HSG through 30 minutes after the procedure
Participants With Adverse Events
Time frame: From administration of the study intervention through 30 minutes after HSG
Most Painful Procedural Step
Time frame: Immediately after HSG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
selim afşar, MD principal investigator
Balikesir University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin 100Mg Suppository and Lidocaine %2 ampoule in people with Hysterosalpingography-Related Pain, run by Balikesir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sıla E DEMİRCAN, MD (+905301540874, silademircan2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Contrast-Medium Injection Measured Using the Numeric Rating Scale (time frame: During HSG, immediately after contrast-medium injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.