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Not yet recruitingNCT07792668HSG-PAINUpdated Oct 15, 2026

Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial

A Phase 4 interventional study of Indomethacin 100Mg Suppository and Lidocaine %2 ampoule in Hysterosalpingography-Related Pain, sponsored by Balikesir University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Balikesir University · Phase 4, Interventional, and Supportive care

Updated Oct 5, 2026Eligibility revisedStart date moved+3 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Hysterosalpingography-Related Pain

Keywords

  • Hysterosalpingography
  • Procedural Pain
  • Indomethacin
  • Paracervical Block
  • Lidocaine
  • Infertility
03

In context

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's planned enrollment of 180 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

Balikesir University is the lead sponsor of 62 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 5, 2026. See what changed

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

Exclusion Criteria:

  • Pregnancy or suspected pregnancy.
  • Active pelvic inflammatory disease or active genital tract infection.
  • Known allergy or 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • No intervention
    No Premedication

    Participants will undergo standard hysterosalpingography without analgesic or local anesthetic premedication.

  • Active comparator
    Rectal Indomethacin

    Participants will receive a single 100 mg rectal indomethacin suppository 30 minutes before hysterosalpingography.

    Drug: Indomethacin 100Mg Suppository

  • Active comparator
    Paracervical Block With Lidocaine

    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.

    Drug: Lidocaine %2 ampoule

Interventions

  • DrugIndomethacin 100Mg Suppository

    A 100 mg indomethacin suppository will be administered rectally 30 minutes before hysterosalpingography.

  • DrugLidocaine %2 ampoule

    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.

06

What researchers measure

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 injection

Secondary 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 insertion

  2. 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 grasping

  4. 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 HSG

  5. 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.

    Time frame: During HSG, immediately after cannula or catheter placement

  6. Pain Intensity During Cervical Traction

    Pain intensity measured using an 11-point NRS ranging from 0 to 10.

    Time frame: During HSG, immediately after cervical traction

  7. Immediate Post-Procedural Pain Intensity

    Pain intensity measured using an 11-point NRS ranging from 0 to 10.

    Time frame: Within 5 minutes after completion of HSG

  8. Pain Intensity 30 Minutes After HSG

    Pain intensity measured using an 11-point NRS ranging from 0 to 10.

    Time frame: 30 minutes after completion of HSG

  9. 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

    Time frame: On the day HSG, from the pre-randomization assessment to contrast injection

  10. Requirement for Rescue Analgesia

    Number/percentage requiring additional analgesia.

    Time frame: From completion of HSG through 30 minutes after the procedure

  11. Participants With Adverse Events

    Nausea, vomiting, dizziness, vasovagal symptoms, allergic symptoms, rectal discomfort, injection-site bleeding/hematoma, severe cramping, etc.

    Time frame: From administration of the study intervention through 30 minutes after HSG

  12. Most Painful Procedural Step

    Participant-reported most painful step during HSG.

    Time frame: Immediately after HSG

07

Study locations

No study locations are listed for this record.

08

Updates

2 registry updates since Sep 25, 2026
Start date
Sep 1, 2026→Nov 1, 2026
Oct 1, 2026
Study completion
Aug 1, 2027→Nov 1, 2027
Oct 1, 2026
Eligibility
Criteria revised in 2 updates
What changed on Oct 1, 2026
Inclusion criteria
  • RemovedFemale participants aged 18 to 45 years
  • RemovedScheduled for diagnostic hysterosalpingography as part of infertility evaluation
  • RemovedAble to understand the study procedures and provide written informed consent
  • RemovedAble to report pain intensity using a 0-to-10 Numeric Rating Scale
  • RemovedHysterosalpingography scheduled during the appropriate menstrual-cycle period according to routine institutional practice
  • RemovedPregnancy excluded before hysterosalpingography according to routine institutional practice
  • AddedFemale 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 in the appropriate menstrual-cycle window according to local clinical protocol Pregnancy excluded according to local clinical protocol
Exclusion criteria
  • RemovedPregnancy or suspected pregnancy
  • RemovedActive pelvic inflammatory disease or active genital tract infection
  • RemovedKnown hypersensitivity or contraindication to indomethacin or other nonsteroidal anti-inflammatory drugs
  • RemovedKnown hypersensitivity to lidocaine or other amide-type local anesthetics
  • RemovedKnown hypersensitivity to the contrast medium used for hysterosalpingography
  • RemovedActive peptic ulcer disease or a history of clinically significant gastrointestinal bleeding
  • RemovedSignificant renal or hepatic disease
  • RemovedClinically significant bleeding disorder
  • RemovedCurrent anticoagulant therapy
  • RemovedUse of systemic analgesic, sedative, or antispasmodic medication within the predefined period before hysterosalpingography
  • RemovedChronic pelvic pain requiring regular analgesic treatment
  • RemovedSevere dysmenorrhea requiring regular analgesic treatment
  • RemovedCervical stenosis requiring anesthesia for hysterosalpingography Inability to provide reliable pain scores
  • AddedPregnancy or suspected pregnancy Active pelvic inflammatory disease or active genital tract infection Known allergy or contraindication to indomethacin, NSAIDs, lidocaine, or amide-type local anesthetics Known contrast-media allergy Active peptic ulcer disease or significant history of gastrointestinal bleeding Significant renal, hepatic, cardiovascular, or 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
What changed on Oct 5, 2026
Inclusion criteria
  • RemovedFemale 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 in the appropriate menstrual-cycle window according to local clinical protocol Pregnancy excluded according to local clinical protocol
  • AddedFemale patients aged 18-45 years.
  • AddedScheduled for diagnostic hysterosalpingography (HSG) as part of infertility evaluation.
  • AddedAble to understand the study and provide written informed consent.
  • AddedAble to report pain using a 0-10 Numeric Rating Scale (NRS).
  • AddedHSG scheduled within the appropriate menstrual-cycle window according to the local clinical protocol.
  • AddedPregnancy excluded according to the local clinical protocol.
Exclusion criteria
  • RemovedPregnancy or suspected pregnancy Active pelvic inflammatory disease or active genital tract infection Known allergy or contraindication to indomethacin, NSAIDs, lidocaine, or amide-type local anesthetics Known contrast-media allergy Active peptic ulcer disease or significant history of gastrointestinal bleeding Significant renal, hepatic, cardiovascular, or 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
  • AddedPregnancy or suspected pregnancy.
  • AddedActive pelvic inflammatory disease or active genital tract infection.
  • AddedKnown allergy or contraindication to indomethacin, nonsteroidal anti-inflammatory drugs (NSAIDs), lidocaine, or amide-type local anesthetics.
  • AddedKnown contrast-media allergy.
  • AddedActive peptic ulcer disease or a significant history of gastrointestinal bleeding.
  • AddedSignificant renal, hepatic, or cardiovascular disease; a bleeding disorder; or current anticoagulant therapy.
  • AddedUse of systemic analgesics, sedatives, or antispasmodics within the protocol-defined pre-HSG window.
  • AddedChronic pelvic pain or severe dysmenorrhea requiring regular analgesic treatment.
  • AddedCervical stenosis requiring anesthesia or anticipated difficult cannulation.
  • AddedInability to provide reliable pain scores or refusal to participate.
across 2 updates, Oct 1, 2026 – Oct 5, 2026
Interventions
Added Drug: Indomethacin 100Mg Suppository; removed Drug: Indomethacin 25 MG/50 MG
Oct 1, 2026
Secondary outcomes
Revised in 2 updates
What changed on Oct 1, 2026
  • AddedCorrelation Between Preprocedural State Anxiety and Pain During Contrast InjectionTime frame: On the day of HSG, from the pre-randomization assessment through contrast injection.
  • AddedCorrelation Between Expected HSG Pain and Pain During Contrast İnjectionTime frame: On the day HSG, from the pre-randomization assessment to contrast injection
  • RemovedPreprocedural State AnxietyTime frame: After informed consent and before randomization and administration of the study intervention
  • RemovedAnticipated HSG PainTime frame: Before randomization and administration of the study intervention.
  • Time frameParticipant Satisfaction With Pain ControlImmediately after HSG. → 30 minutes after completion of HSG
What changed on Oct 5, 2026
  • DescriptionPain Intensity During Cannula or Catheter Placement: how it is measured was reworded
  • DescriptionPain Intensity During Cervical Grasping: how it is measured was reworded
  • DescriptionPain Intensity During Speculum Insertion: how it is measured was reworded
across 2 updates, Oct 1, 2026 – Oct 5, 2026
Design
Phase 3→Phase 4
Oct 1, 2026
Show all 2 updates
  1. Oct 5, 2026
    Eligibility 6 inclusion criteria added, 1 removed; 10 exclusion criteria added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedFemale 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 in the appropriate menstrual-cycle window according to local clinical protocol Pregnancy excluded according to local clinical protocol
    • AddedFemale patients aged 18-45 years.
    • AddedScheduled for diagnostic hysterosalpingography (HSG) as part of infertility evaluation.
    • AddedAble to understand the study and provide written informed consent.
    • AddedAble to report pain using a 0-10 Numeric Rating Scale (NRS).
    • AddedHSG scheduled within the appropriate menstrual-cycle window according to the local clinical protocol.
    • AddedPregnancy excluded according to the local clinical protocol.
    Exclusion criteria
    • RemovedPregnancy or suspected pregnancy Active pelvic inflammatory disease or active genital tract infection Known allergy or contraindication to indomethacin, NSAIDs, lidocaine, or amide-type local anesthetics Known contrast-media allergy Active peptic ulcer disease or significant history of gastrointestinal bleeding Significant renal, hepatic, cardiovascular, or 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
    • AddedPregnancy or suspected pregnancy.
    • AddedActive pelvic inflammatory disease or active genital tract infection.
    • AddedKnown allergy or contraindication to indomethacin, nonsteroidal anti-inflammatory drugs (NSAIDs), lidocaine, or amide-type local anesthetics.
    • AddedKnown contrast-media allergy.
    • AddedActive peptic ulcer disease or a significant history of gastrointestinal bleeding.
    • AddedSignificant renal, hepatic, or cardiovascular disease; a bleeding disorder; or current anticoagulant therapy.
    • AddedUse of systemic analgesics, sedatives, or antispasmodics within the protocol-defined pre-HSG window.
    • AddedChronic pelvic pain or severe dysmenorrhea requiring regular analgesic treatment.
    • AddedCervical stenosis requiring anesthesia or anticipated difficult cannulation.
    • AddedInability to provide reliable pain scores or refusal to participate.
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionPain Intensity During Cannula or Catheter Placement: how it is measured was reworded
    • DescriptionPain Intensity During Cervical Grasping: how it is measured was reworded
    • DescriptionPain Intensity During Speculum Insertion: how it is measured was reworded
    + 1 other change: verification date
  2. Oct 1, 2026
    Start date Sep 1, 2026→Nov 1, 2026
    Study completion Aug 1, 2027→Nov 1, 2027
    Eligibility 1 inclusion criterion added, 6 removed; 1 exclusion criterion added, 13 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedFemale participants aged 18 to 45 years
    • RemovedScheduled for diagnostic hysterosalpingography as part of infertility evaluation
    • RemovedAble to understand the study procedures and provide written informed consent
    • RemovedAble to report pain intensity using a 0-to-10 Numeric Rating Scale
    • RemovedHysterosalpingography scheduled during the appropriate menstrual-cycle period according to routine institutional practice
    • RemovedPregnancy excluded before hysterosalpingography according to routine institutional practice
    • AddedFemale 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 in the appropriate menstrual-cycle window according to local clinical protocol Pregnancy excluded according to local clinical protocol
    Exclusion criteria
    • RemovedPregnancy or suspected pregnancy
    • RemovedActive pelvic inflammatory disease or active genital tract infection
    • RemovedKnown hypersensitivity or contraindication to indomethacin or other nonsteroidal anti-inflammatory drugs
    • RemovedKnown hypersensitivity to lidocaine or other amide-type local anesthetics
    • RemovedKnown hypersensitivity to the contrast medium used for hysterosalpingography
    • RemovedActive peptic ulcer disease or a history of clinically significant gastrointestinal bleeding
    • RemovedSignificant renal or hepatic disease
    • RemovedClinically significant bleeding disorder
    • RemovedCurrent anticoagulant therapy
    • RemovedUse of systemic analgesic, sedative, or antispasmodic medication within the predefined period before hysterosalpingography
    • RemovedChronic pelvic pain requiring regular analgesic treatment
    • RemovedSevere dysmenorrhea requiring regular analgesic treatment
    • RemovedCervical stenosis requiring anesthesia for hysterosalpingography Inability to provide reliable pain scores
    • AddedPregnancy or suspected pregnancy Active pelvic inflammatory disease or active genital tract infection Known allergy or contraindication to indomethacin, NSAIDs, lidocaine, or amide-type local anesthetics Known contrast-media allergy Active peptic ulcer disease or significant history of gastrointestinal bleeding Significant renal, hepatic, cardiovascular, or 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
    Secondary outcomes 1 time frame changed, 2 added, 2 removed
    What changed in the outcomes
    • AddedCorrelation Between Preprocedural State Anxiety and Pain During Contrast InjectionTime frame: On the day of HSG, from the pre-randomization assessment through contrast injection.
    • AddedCorrelation Between Expected HSG Pain and Pain During Contrast İnjectionTime frame: On the day HSG, from the pre-randomization assessment to contrast injection
    • RemovedPreprocedural State AnxietyTime frame: After informed consent and before randomization and administration of the study intervention
    • RemovedAnticipated HSG PainTime frame: Before randomization and administration of the study intervention.
    • Time frameParticipant Satisfaction With Pain ControlImmediately after HSG. → 30 minutes after completion of HSG
    Interventions Added Drug: Indomethacin 100Mg Suppository; removed Drug: Indomethacin 25 MG/50 MG
    Design Phase 3→Phase 4
    + 4 other changes: index terms, verification date, description and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07792668
Lead sponsor
Balikesir University
Responsible party
Ecem Sila Demircan (OB/GYN resident, Balikesir University) — Principal investigator
First posted
Aug 28, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Sıla E DEMİRCAN, MD
Contact
silademircan2008@gmail.com
+905301540874
selim afşar, MD
principal investigator · Balikesir University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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