Pain ManagementHARPNCT07178379
Hysteroscopy Anesthesia for Relief of Pain
A study testing Local paracervical Anesthesia in people with Pain Management and Outpatient Hysteroscopy, run by Maimónides Biomedical Research Institute of Córdoba.
Trial summary
This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, Outpatient Hysteroscopy, Local Anesthesia
- What is being tested?
- Local paracervical Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent.
- Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes.
- Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy
- No previous hysteroscopies
Who cannot join
- Age < 18 years
- Known allergy to any local anesthetic
- General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc.
- Complex procedures like myomectomy with morcellator
- Failure to access the uterine cavity
- Anatomic conditions preventing cavity access
Show all 12Show fewer
- Excessive procedure duration or fluid use (fluid deficit > 1000 cc)
- Known uterine malformations
- Waiting times exceeding 60 minutes
- Use of analgesic medication prior to the procedure
- Major complications related to the procedure including uterine perforation, creation of a false passage, or significant bleeding requiring interventions beyond standard care.
- Incomplete delivery of informed consent or failure to complete the pre-procedure anxiety questionnaire.
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: HARP Trial: Hysteroscopy Anesthesia for Relief of Pain
This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured.
This study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS).
Read more
The primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates.
Patients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis.
Inclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent.
A total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled.
The results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.
- Conditions
- Pain Management, Outpatient Hysteroscopy, Local Anesthesia, Procedural Pain Relief, Gynecologic Procedure
- Being tested
- Local paracervical Anesthesia, Placebo
- Keywords
- hysteroscoy, outpatient hysteroscopy, pain assessment, visual analog scale, localanesthesia, ambulatory surgery, randomized controlled trial
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local paracervical AnesthesiaProcedure or surgery
Also called local anesthesia, mepivacaine, Mepivacaine 3% uterosacral ligament block
- Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic).
Dose/Administration:
Drug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side).
Technique:
Patient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy.
PlaceboOther
Also called Saline irrigation (sham procedure), Non-pharmacological
Procedure:
Vaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration).
Mimicry:
Same equipment (syringe, speculum) as intervention group. Identical patient positioning and timing
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients in the control group will undergo a placebo-like intervention in which the vagina and cervix will be irrigated with 0.9% normal saline using a syringe, simulating the motion and timing of the anesthetic application without actual injection. This aims to reduce expectation bias. No active anesthetic agent will be used.
Intervention Type: Placebo Comparator Substance: Saline (0.9% sodium chloride) Route: Vaginal and cervical irrigation Purpose: To serve as the control arm for comparison of pain levels in patients not receiving anesthetic injections. Receives: Other: Placebo |
| Local Anesthesia (Mepivacaine 3%) | Experimental | Patients in this group will receive an injection of 3% mepivacaine into the uterosacral ligaments before undergoing diagnostic hysteroscopy. The anesthetic will be administered using a 25 mm Carpule needle, with 3.4 mL injected into each uterosacral ligament under standard gynecological positioning. The procedure will begin approximately one minute after administration to allow time for the anesthetic effect.
Intervention Type: Drug Drug Name: Mepivacaine 3% Dose and Route: Local injection - 6.8 mL total (3.4 mL per side) Purpose: To assess the effect of local anesthesia on pain perception during outpatient hysteroscopy. Receives: Procedure: Local paracervical Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during hysteroscopy
Pain will be measured using a 10-point Visual Analog Scale (VAS) immediately after the procedure. Patients will be asked to rate the maximum pain experienced during the hysteroscopy.
Measure Type: Continuous (VAS score 0-10) Unit of Measure: Points on VAS scale Method of Aggregation: Mean (± SD) Statistical Analysis Plan: Comparison between groups using Student's t-test or Mann-Whitney U test depending on normality.
Measured: Immediately after the procedure
Secondary outcomes (3)
Need for post-procedure analgesia
Whether patients required any analgesic medication after the hysteroscopy, and what type.
Measure Type: Binary (Yes/No), plus qualitative record of analgesic used Unit of Measure: Proportion of patients (%)
Measured: Within 30 minutes post-procedure
Procedure-related complications
Description:
Recording of any intraoperative or immediate postoperative complications (e.g., vasovagal episodes, perforation, bleeding).
Measure Type: Binary (Yes/No), with qualitative subtype Unit of Measure: Number of events
Measured: During and immediately after the procedure
Indication for surgical hysteroscopy due to intolerable pain
Description:
Whether the patient had to be referred for surgical hysteroscopy under anesthesia due to failure or intolerance of office hysteroscopy.
Measure Type: Binary (Yes/No) Unit of Measure: Number of cases
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start6 Sep 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Caballero, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- Jorge Garcia Fernandez, MD, Principal Investigator, Principal investigator, MD Obstetrics and Gynecology Reina Sofia Hospital, Cordoba, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178379
- Sponsor's protocol ID
- HARP
- Acronym
- HARP
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Al-Sunaidi M, Tulandi T. A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy. J Minim Invasive Gynecol. 2007 Mar-Apr;14(2):153-5. doi: 10.1016/j.jmig.2006.09.007.
PubMed 17368248Kokanali MK, Guzel AI, Ozer I, Topcu HO, Cavkaytar S, Doganay M. Pain experienced during and after office hysteroscopy with and without intracervical anesthesia. J Exp Ther Oncol. 2014;10(4):243-6.
PubMed 25509976Vercellini P, Colombo A, Mauro F, Oldani S, Bramante T, Crosignani PG. Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril. 1994 Nov;62(5):1083-5.
PubMed 7646610Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130.
PubMed 20332307Ahmad G, Saluja S, O'Flynn H, Sorrentino A, Leach D, Watson A. Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev. 2017 Oct 5;(10)(10):CD007710. doi: 10.1002/14651858.CD007710.pub3.
PubMed 35611933De Silva PM, Carnegy A, Smith PP, Clark TJ. Local anaesthesia for office hysteroscopy: A systematic review & meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:70-81. doi: 10.1016/j.ejogrb.2020.05.062. Epub 2020 Jun 2.
PubMed 32570188Huang L, Yu Q, Zhu Z, Huang P, Ding X, Ma X, Chen Y, Su D. The Current Situation of Anaesthesia for Hysteroscopy in Mainland China: A National Survey. J Pers Med. 2023 Sep 26;13(10):1436. doi: 10.3390/jpm13101436.
PubMed 37888047Nowak A, Chmaj-Wierzchowska K, Lach A, Malinger A, Wilczak M. Evaluation of Pain During Hysteroscopy Under Local Anesthesia, Including the Stages of the Procedure. J Clin Med. 2024 Nov 21;13(23):7030. doi: 10.3390/jcm13237030.
PubMed 39685488
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARP Trial: Hysteroscopy Anesthesia for Relief of Pain
- ClinicalTrials.gov ID
- NCT07178379
- Acronym / sponsor ID
- HARP / HARP
- Conditions
- Pain Management, Outpatient Hysteroscopy, Local Anesthesia, Procedural Pain Relief, Gynecologic Procedure
- Keywords
- hysteroscoy, outpatient hysteroscopy, pain assessment, visual analog scale, localanesthesia, ambulatory surgery, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 6 Sep 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Sep 2025 (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.
This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured.
This study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS).
The primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates.
Patients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis.
Inclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent.
A total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled.
The results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboPatients in the control group will undergo a placebo-like intervention in which the vagina and cervix will be irrigated with 0.9% normal saline using a syringe, simulating the motion and timing of the anesthetic application without actual injection. This aims to reduce expectation bias. No active anesthetic agent will be used. Intervention Type: Placebo Comparator Substance: Saline (0.9% sodium chloride) Route: Vaginal and cervical irrigation Purpose: To serve as the control arm for comparison of pain levels in patients not receiving anesthetic injections. |
| Local Anesthesia (Mepivacaine 3%) | Experimental | Procedure: Local paracervical AnesthesiaPatients in this group will receive an injection of 3% mepivacaine into the uterosacral ligaments before undergoing diagnostic hysteroscopy. The anesthetic will be administered using a 25 mm Carpule needle, with 3.4 mL injected into each uterosacral ligament under standard gynecological positioning. The procedure will begin approximately one minute after administration to allow time for the anesthetic effect. Intervention Type: Drug Drug Name: Mepivacaine 3% Dose and Route: Local injection - 6.8 mL total (3.4 mL per side) Purpose: To assess the effect of local anesthesia on pain perception during outpatient hysteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent.
- Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes.
- Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy
- No previous hysteroscopies
Key exclusion criteria (12 listed)
- Age < 18 years
- Known allergy to any local anesthetic
- General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc.
- Complex procedures like myomectomy with morcellator
- Failure to access the uterine cavity
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 |
|---|---|---|
| Local paracervical AnesthesiaAlso: local anesthesia, mepivacaine, Mepivacaine 3% uterosacral ligament block1. Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic). Dose/Administration: Drug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side). Technique: Patient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy. | Procedure or surgery | Local Anesthesia (Mepivacaine 3%) |
| PlaceboAlso: Saline irrigation (sham procedure), Non-pharmacologicalProcedure: Vaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration). Mimicry: Same equipment (syringe, speculum) as intervention group. Identical patient positioning and timing | Other | Control |
Primary outcome
Pain intensity during hysteroscopy
Time frame: Immediately after the procedure
Pain will be measured using a 10-point Visual Analog Scale (VAS) immediately after the procedure. Patients will be asked to rate the maximum pain experienced during the hysteroscopy. Measure Type: Continuous (VAS score 0-10) Unit of Measure: Points on VAS scale Method of Aggregation: Mean (± SD) Statistical Analysis Plan: Comparison between groups using Student's t-test or Mann-Whitney U test depending on normality.
3 secondary outcomes
Need for post-procedure analgesia
Time frame: Within 30 minutes post-procedure
Procedure-related complications
Time frame: During and immediately after the procedure
Indication for surgical hysteroscopy due to intolerable pain
Time frame: Immediately post-procedure
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 17 Sep 2025.
- Results publication: PubMed 17368248Al-Sunaidi M, Tulandi T. A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy. J Minim Invasive Gynecol. 2007 Mar-Apr;14(2):153-5. doi: 10.1016/j.jmig.2006.09.007.
- Results publication: PubMed 25509976Kokanali MK, Guzel AI, Ozer I, Topcu HO, Cavkaytar S, Doganay M. Pain experienced during and after office hysteroscopy with and without intracervical anesthesia. J Exp Ther Oncol. 2014;10(4):243-6.
- Results publication: PubMed 7646610Vercellini P, Colombo A, Mauro F, Oldani S, Bramante T, Crosignani PG. Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril. 1994 Nov;62(5):1083-5.
- Results publication: PubMed 20332307Cooper NA, Khan KS, Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ. 2010 Mar 23;340:c1130. doi: 10.1136/bmj.c1130.
- Results publication: PubMed 35611933Ahmad G, Saluja S, O'Flynn H, Sorrentino A, Leach D, Watson A. Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev. 2017 Oct 5;(10)(10):CD007710. doi: 10.1002/14651858.CD007710.pub3.
- Results publication: PubMed 32570188De Silva PM, Carnegy A, Smith PP, Clark TJ. Local anaesthesia for office hysteroscopy: A systematic review & meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:70-81. doi: 10.1016/j.ejogrb.2020.05.062. Epub 2020 Jun 2.
- Results publication: PubMed 37888047Huang L, Yu Q, Zhu Z, Huang P, Ding X, Ma X, Chen Y, Su D. The Current Situation of Anaesthesia for Hysteroscopy in Mainland China: A National Survey. J Pers Med. 2023 Sep 26;13(10):1436. doi: 10.3390/jpm13101436.
- Results publication: PubMed 39685488Nowak A, Chmaj-Wierzchowska K, Lach A, Malinger A, Wilczak M. Evaluation of Pain During Hysteroscopy Under Local Anesthesia, Including the Stages of the Procedure. J Clin Med. 2024 Nov 21;13(23):7030. doi: 10.3390/jcm13237030.
- Individual participant dataSharing planned: Yes
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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.
Jorge Garcia Fernandez, MD, Principal Investigator principal investigator
MD Obstetrics and Gynecology Reina Sofia Hospital, Cordoba, Spain
Questions about this trial
What is this clinical trial studying?
A study testing Local paracervical Anesthesia in people with Pain Management and Outpatient Hysteroscopy, run by Maimónides Biomedical Research Institute of Córdoba.
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 4 inclusion and 12 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 17 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
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 Jorge Garcia Fernandez, MD, Principal Investigator (+34 622595644, jorgarciafernan@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 hysteroscopy (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178379, which also lists 8 linked publications.
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 17 Sep 2025.