PainNCT05801172
Managing Outpatient Hysteroscopy-associated Pain
A study testing ketoprofen for pain relief in office hysteroscopy, ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy and ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy in people with Pain and Hysteroscopic Surgery, run by Jagiellonian University at 1 site in Poland.
Trial summary
Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Pain, Hysteroscopic Surgery
- What is being tested?
- ketoprofen for pain relief in office hysteroscopy, ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy and ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18
- indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility
Who cannot join
- allergies to medications
- refusal to consent to the procedure or participation in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, 31-501
About this study
Official title: Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?
Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.
Read the detailed description
A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.
- Conditions
- Pain, Hysteroscopic Surgery
- Being tested
- ketoprofen for pain relief in office hysteroscopy, ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy, ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoprofen for pain relief in office hysteroscopyProcedure or surgery
ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy
ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopyProcedure or surgery
ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure
ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopyProcedure or surgery
ketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in paracervical block at the start of the procedure
| Study group | Role | What they receive |
|---|---|---|
| A (NSAID) | Active comparator | ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy Receives: Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy; Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy |
| B (A+infiltration anesthesia) | Active comparator | ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure Receives: Procedure: ketoprofen for pain relief in office hysteroscopy; Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy |
| C (A+paracervical block) | Active comparator | ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure Receives: Procedure: ketoprofen for pain relief in office hysteroscopy; Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensification of pain in Numeric Rating Scale: 0-10
Measurement and comparison of the intensity of pain in numeric rating scale (NRS) during and after the procedure in 3 study arms
Measured: up to 6 months
Secondary outcomes (3)
Intensity of cervical bleeding on the assumed scale: 0-3
Measurement and comparison of the intensity of cervical bleeding (intensity scale: 0-3) during the procedure in 3 study arms
Measured: up to 6 months
Occurrence of vaso-vagal reaction during the procedure
Measurement and comparison of the frequency of vaso-vagal reaction during the procedure in 3 study arms
Measured: up to 6 months
Occurrence of abandoning/ limiting the procedure
Measurement and comparison of the frequency of abandoning/ limiting the procedure due to pain in 3 study arms
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Jul 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine).
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801172
- Sponsor's protocol ID
- 1072.6120.228.2021
- Status last verified
- Aug 2023
- First submitted
- 11 Mar 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?
- ClinicalTrials.gov ID
- NCT05801172
- Acronym / sponsor ID
- 1072.6120.228.2021
- Conditions
- Pain, Hysteroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 6 Apr 2023 (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.
Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.
Detailed description
A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine).
| Arm | Type | Receives |
|---|---|---|
| A (NSAID) | Active comparator | Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy, Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopyketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy |
| B (A+infiltration anesthesia) | Active comparator | Procedure: ketoprofen for pain relief in office hysteroscopy, Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopyketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure |
| C (A+paracervical block) | Active comparator | Procedure: ketoprofen for pain relief in office hysteroscopy, Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopyketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18
- indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility
Key exclusion criteria (2 listed)
- allergies to medications
- refusal to consent to the procedure or participation in the study
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 |
|---|---|---|
| ketoprofen for pain relief in office hysteroscopyketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy | Procedure or surgery | B (A+infiltration anesthesia), C (A+paracervical block) |
| ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopyketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure | Procedure or surgery | A (NSAID), C (A+paracervical block) |
| ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopyketoprofen ketoprofen 100 mg intravenously 30 minutes pre-procedure for pain relief in office hysteroscopy plus 20 ml 1% lidocaine in paracervical block at the start of the procedure | Procedure or surgery | A (NSAID), B (A+infiltration anesthesia) |
Primary outcome
Intensification of pain in Numeric Rating Scale: 0-10
Time frame: up to 6 months
Measurement and comparison of the intensity of pain in numeric rating scale (NRS) during and after the procedure in 3 study arms
3 secondary outcomes
Intensity of cervical bleeding on the assumed scale: 0-3
Time frame: up to 6 months
Occurrence of vaso-vagal reaction during the procedure
Time frame: up to 6 months
Occurrence of abandoning/ limiting the procedure
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert Jach, Prof. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketoprofen for pain relief in office hysteroscopy, ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy and ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy in people with Pain and Hysteroscopic Surgery, run by Jagiellonian University at 1 site in Poland.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensification of pain in Numeric Rating Scale: 0-10 (time frame: up to 6 months). 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 8 Aug 2023.