Proctological SurgeryPhase 4NCT04530903
Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery.
A Phase 4 study testing Clonidine, Levobupivacaine and NaCl 0.9% in people with Proctological Surgery, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain. Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctological Surgery
- What is being tested?
- Clonidine, Levobupivacaine and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2020to 1 Jan 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Signature of informed consent
Who cannot join
- Refusal to participate ;
- Allergy to either local anaesthetics or clonidine;
- Local infectious pathologies (e.g. acute ano-perineal suppuration)
- Pregnancy
- Breastfeeding
- Severe bradyarrhythmia due to sinus node disease or second and third degree atrioventricular block
Show all 13Show fewer
- Severe depressive condition
- Severe coronary artery disease
- Raynaud's disease
- Heart failure
- Obliterating thromboangiitis
- Epilepsy
- Spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Saint-Pierre
Brussels, 1000
Panayota Kapessidou, MD,PhD, +32.2.535 ext. 3750, pkapessi@ulb.ac.be
Myriam Suball, MD, +32.2.535 ext. 3756, myriam_suball@stpierre-bru.be
About this study
Official title: Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective
Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain.
Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation.
Read more
The ideal pain management procedures are based on the multimodal analgesia model, based in turn on the combination of products and / or techniques to improve the quality of analgesia, reduce the side effects linked to the use of opioids, reduce responses to surgical stress, reduce postoperative recovery and allow rapid rehabilitation of the patient.
The aim of our study is to investigate whether clonidine combined with levobupivacaine in the pudendal block reduce the total consumption of opioids in proctological surgery.
- Conditions
- Proctological Surgery
- Being tested
- Clonidine, Levobupivacaine, NaCl 0.9%
- Keywords
- Post-operative Pain, Pudendal Block, Clonidine, Levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Catapressan
75 µg (0.5mL) per injection site
LevobupivacaineDrug
Also called Chirocaine
0.25% (10 ml) per injection site
NaCl 0.9%Drug
Nacl 0.9% (0.5ml) per injection site
| Study group | Role | What they receive |
|---|---|---|
| Group Clonidine | Experimental | Group Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side. Receives: Drug: Clonidine; Drug: Levobupivacaine |
| Control | Placebo comparator | Group Control will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine per side; 0.5 ml of 0.9% NaCl will be added to each syringe to homogenise the volume in order to remain blind. Receives: Drug: Levobupivacaine; Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Dose of Opioids consumed in the intraoperative period
Total consumption of sufentanyl during the intraoperative period (in micrograms). The administration of sufentanyl depends on the change of physiological parameters (augmentation of 20% of blood pressure and/or cardiac frequency).
Measured: up to 24 hours post-surgery
Secondary outcomes (10)
Total Dose of tramadol consumed in the recovery room
In the recovery room, dose of tramadol (in milligrams, intravenous administration). The administration of tramadol depends on Visual Analogic Pain Score (VAS>4) (scale = 0 no pain; 10 = worst pain imaginable)
Measured: up to 24 hours post-surgery
Total consumption of tramadol in post-operative period
Total consumption of tramadol from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable).
Tramadol (dose in milligrams, oral administration)
Measured: up to 24 hours post-surgery
Need for tramadol administration per patient during the first 24 hours
Number of Tramadol dose requested by the patient during the first 24 hours
Measured: up to 24 hours post-surgery
Total Dose of piritramide consumed in the recovery room
In the recovery room, dose of piritramide (in milligrams, intravenous administration). The administration of piritramide depends on Visual Analogic Pain Score (VAS>4) (scale = 0 no pain; 10 = worst pain imaginable)
Measured: up to 24 hours post-surgery
Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)
Number of Piritramid dose requested by the patient during the hospitalization in Post Anesthesia Care Unit (PACU)
Measured: during the hospitalization in Post Anesthesia Care Unit (PACU)
Total consumption of paracetamol in post-operative period
Total consumption of paracetamol from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable). Paracetamol (dose in grams, oral administration)
Measured: up to 24 hours post-surgery
Total consumption of diclofenac in post-operative period
Total consumption of diclofenac from the exit of the recovery room to the day after the surgery based on Visual Analogic Pain Score >4 (scale = 0 no pain; 10 = worst pain imaginable).
Diclofenac (dose in milligrams, oral administration)
Measured: up to 24 hours post-surgery
Time before First Use of Rescue Analgesic
Time between the completion of the block and the first post-operative administration of rescue analgesics (Tramadol and/or Piritramide on request)
Measured: up to 24 hours post-surgery
Post-operative Pain as assessed by Visual Analog Scale
Post-operative Pain levels will be determined every 15 minutes in the recovery room, then every hour until discharge and on Day 1 at home; Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
Measured: up to 24 hours post-surgery
Patient satisfaction
Level of satisfaction assessed on a 5-point scale (from 1 to 5): 1 not satisfied, 2 not very satisfied, 3 moderately satisfied, 4 satisfied, 5 very satisfied.
Measured: up to 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start9 Sep 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Proctological SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, MD,PhD, Study director, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)Myriam Suball, MD, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)Marzia Gambassi, MD, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530903
- Sponsor's protocol ID
- B076202042809
- Status last verified
- Sep 2020
- First submitted
- 18 Jun 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
PubMed 15763418Ceulemans A, De Looze D, Van de Putte D, Stiers E, Coppens M. High post-operative pain scores despite multimodal analgesia in ambulatory anorectal surgery: a prospective cohort study. Acta Chir Belg. 2019 Aug;119(4):224-230. doi: 10.1080/00015458.2018.1500802. Epub 2018 Sep 7.
PubMed 30189793Joshi GP, Neugebauer EA; PROSPECT Collaboration. Evidence-based management of pain after haemorrhoidectomy surgery. Br J Surg. 2010 Aug;97(8):1155-68. doi: 10.1002/bjs.7161.
PubMed 20593430Comite douleur-anesthesie locoregionale et le comite des referentiels de la Sfar. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. No abstract available. French.
PubMed 19026514Novikova N, Cluver C. Local anaesthetic nerve block for pain management in labour. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD009200. doi: 10.1002/14651858.CD009200.pub2.
PubMed 22513972Vinson-Bonnet B.. Le bloc pudendal: technique d'analgésie postopératoire en chirurgie proctologique. Pelvi-Périnéologie 2007, 2(2):180-183.
Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.
PubMed 15625258Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Imbelloni LE, Vieira EM, Gouveia MA, Netinho JG, Spirandelli LD, Cordeiro JA. Pudendal block with bupivacaine for postoperative pain relief. Dis Colon Rectum. 2007 Oct;50(10):1656-61. doi: 10.1007/s10350-007-0216-7.
PubMed 17701375De La Arena P.. Bloc pudendal sous échographie: faisabilité et efficacité peropératoire chez l'enfant. Annales Françaises d'Anesthésie et de Réanimation 2014; A398-A403.
Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.
PubMed 29205687Li A, Wei Z, Liu Y, Shi J, Ding H, Tang H, Zheng P, Gao Y, Feng S. Ropivacaine versus levobupivacaine in peripheral nerve block: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Apr;96(14):e6551. doi: 10.1097/MD.0000000000006551.
PubMed 28383425Malav K, Singariya G, Mohammed S, Kamal M, Sangwan P, Paliwal B. Comparison of 0.5% Ropivacaine and 0.5% Levobupivacaine for Sciatic Nerve Block Using Labat Approach in Foot and Ankle Surgery. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):15-20. doi: 10.5152/TJAR.2017.03411. Epub 2017 Nov 27.
PubMed 30140496Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
PubMed 21956081Kirksey MA, Haskins SC, Cheng J, Liu SS. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015 Sep 10;10(9):e0137312. doi: 10.1371/journal.pone.0137312. eCollection 2015.
PubMed 26355598
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Clonidine in Association With Levobupivacaine Performing a Pudendal Block in Proctological Surgery: Pilot Study, Prospective
- ClinicalTrials.gov ID
- NCT04530903
- Acronym / sponsor ID
- B076202042809
- Conditions
- Proctological Surgery
- Keywords
- Post-operative Pain, Pudendal Block, Clonidine, Levobupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 28 Aug 2020 (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.
Proctological surgery represents a short duration surgery performed in ambulatory, which causes significant post-operative pain.
Post-operative pain resulting from proctological surgery is greater than 5 on the Visual Analog Scale (VAS) within the first 24 hours and it revives during the first defecation.
The ideal pain management procedures are based on the multimodal analgesia model, based in turn on the combination of products and / or techniques to improve the quality of analgesia, reduce the side effects linked to the use of opioids, reduce responses to surgical stress, reduce postoperative recovery and allow rapid rehabilitation of the patient.
The aim of our study is to investigate whether clonidine combined with levobupivacaine in the pudendal block reduce the total consumption of opioids in proctological surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Clonidine | Experimental | Drug: Clonidine, Drug: LevobupivacaineGroup Clonidine will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine and 75 µg of clonidine per side. |
| Control | Placebo comparator | Drug: Levobupivacaine, Drug: NaCl 0.9%Group Control will benefit from the pudendal block realised with 10 ml of 0.25% levobupivacaine per side; 0.5 ml of 0.9% NaCl will be added to each syringe to homogenise the volume in order to remain blind. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Signature of informed consent
Key exclusion criteria (13 listed)
- Refusal to participate ;
- Allergy to either local anaesthetics or clonidine;
- Local infectious pathologies (e.g. acute ano-perineal suppuration)
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| ClonidineAlso: Catapressan75 µg (0.5mL) per injection site | Drug | Group Clonidine |
| LevobupivacaineAlso: Chirocaine0.25% (10 ml) per injection site | Drug | Control, Group Clonidine |
| NaCl 0.9%Nacl 0.9% (0.5ml) per injection site | Drug | Control |
Primary outcome
Total Dose of Opioids consumed in the intraoperative period
Time frame: up to 24 hours post-surgery
Total consumption of sufentanyl during the intraoperative period (in micrograms). The administration of sufentanyl depends on the change of physiological parameters (augmentation of 20% of blood pressure and/or cardiac frequency).
10 secondary outcomes
Total Dose of tramadol consumed in the recovery room
Time frame: up to 24 hours post-surgery
Total consumption of tramadol in post-operative period
Time frame: up to 24 hours post-surgery
Need for tramadol administration per patient during the first 24 hours
Time frame: up to 24 hours post-surgery
Total Dose of piritramide consumed in the recovery room
Time frame: up to 24 hours post-surgery
Need for Piritramid administration per patient during the hospitalization in Post Anesthesia Care Unit (PACU)
Time frame: during the hospitalization in Post Anesthesia Care Unit (PACU)
Total consumption of paracetamol in post-operative period
Time frame: up to 24 hours post-surgery
Total consumption of diclofenac in post-operative period
Time frame: up to 24 hours post-surgery
Time before First Use of Rescue Analgesic
Time frame: up to 24 hours post-surgery
Post-operative Pain as assessed by Visual Analog Scale
Time frame: up to 24 hours post-surgery
Patient satisfaction
Time frame: up to 24 hours post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Background: PubMed 15763418Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
- Background: PubMed 30189793Ceulemans A, De Looze D, Van de Putte D, Stiers E, Coppens M. High post-operative pain scores despite multimodal analgesia in ambulatory anorectal surgery: a prospective cohort study. Acta Chir Belg. 2019 Aug;119(4):224-230. doi: 10.1080/00015458.2018.1500802. Epub 2018 Sep 7.
- Background: PubMed 20593430Joshi GP, Neugebauer EA; PROSPECT Collaboration. Evidence-based management of pain after haemorrhoidectomy surgery. Br J Surg. 2010 Aug;97(8):1155-68. doi: 10.1002/bjs.7161.
- Background: PubMed 19026514Comite douleur-anesthesie locoregionale et le comite des referentiels de la Sfar. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. No abstract available. French.
- Background: PubMed 22513972Novikova N, Cluver C. Local anaesthetic nerve block for pain management in labour. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD009200. doi: 10.1002/14651858.CD009200.pub2.
- BackgroundVinson-Bonnet B.. Le bloc pudendal: technique d'analgésie postopératoire en chirurgie proctologique. Pelvi-Périnéologie 2007, 2(2):180-183.
- Background: PubMed 15625258Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 17701375Imbelloni LE, Vieira EM, Gouveia MA, Netinho JG, Spirandelli LD, Cordeiro JA. Pudendal block with bupivacaine for postoperative pain relief. Dis Colon Rectum. 2007 Oct;50(10):1656-61. doi: 10.1007/s10350-007-0216-7.
- BackgroundDe La Arena P.. Bloc pudendal sous échographie: faisabilité et efficacité peropératoire chez l'enfant. Annales Françaises d'Anesthésie et de Réanimation 2014; A398-A403.
- Background: PubMed 29205687Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.
- Background: PubMed 28383425Li A, Wei Z, Liu Y, Shi J, Ding H, Tang H, Zheng P, Gao Y, Feng S. Ropivacaine versus levobupivacaine in peripheral nerve block: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Apr;96(14):e6551. doi: 10.1097/MD.0000000000006551.
- 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.
Panayota Kapessidou, MD,PhD study director
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Myriam Suball, MD principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Marzia Gambassi, MD principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine, Levobupivacaine and NaCl 0.9% in people with Proctological Surgery, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 13 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. 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 Belgium. 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. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panayota Kapessidou, MD,PhD (+32.2.535 ext. 3750, pkapessi@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Dose of Opioids consumed in the intraoperative period (time frame: up to 24 hours post-surgery). 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 NCT04530903, which also lists 19 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 2020.