Uterine LeiomyomasPhase 4NCT02293447

Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

A Phase 4 study testing Lidocaine per-embolization and Lidocaine post-embolization in people with Uterine Leiomyomas, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Uterine Leiomyomas
What is being tested?: Lidocaine per-embolization and Lidocaine post-embolization
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteCanada
Study dates: Nov 2014to Mar 2016
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation;
Patient must be able to provide written, informed consent

Who cannot join

Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;
Personal or familial history of malignant familial hyperthermia;
Documented history of second or third atrio-ventricular heart block
Contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.
History of previous uterine fibroid embolization.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Toronto Western Hospital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study

Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain.

For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups.

This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.

Conditions: Uterine Leiomyomas
Being tested: Lidocaine per-embolization, Lidocaine post-embolization
Keywords: Uterine, Fibroid, Embolization, Leiomyoma, Lidocaine, Pain
Medical subject headings: Myofibroma, Leiomyoma, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine per-embolizationDrug
Also called Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
Lidocaine post-embolizationDrug
Also called Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.

Study groups in NCT02293447
Study group	Role	What they receive
Control	No intervention	The control group will undergo uterine artery embolization according to regular protocol, without the administration of lidocaine.
Lidocaine per-embolization	Experimental	This group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles. Receives: Drug: Lidocaine per-embolization
Lidocaine post-embolization	Experimental	10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved. Receives: Drug: Lidocaine post-embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-Procedural Pain at 4 hours
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) filled by patients at 4h, 7h and 24h post-procedure. At 4h, patients will report the worst pain they experienced since end of procedure. At 7h and 24h, pain at time of assessment will be recorded.
Measured: 4h post-procedure
Post-Procedural Pain at 7 hours
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Measured: 7h post-procedure

Secondary outcomes (3)

Hospital length-of-stay
Estimated in hours, the length-of-stay will be evaluated from the end of procedure to discharge.
Measured: 24 hours post-intervention
Narcotic dose
The total amount on narcotic doses administered to patient during the first 24hours post-procedure will be recorded.
Measured: 24 hours post-intervention
Post-Procedural Pain at 24 hours
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
Measured: 24 hours post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Mar 2016

First posted18 Nov 2014 (estimated)
Study startNov 2014
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Uterine LeiomyomasStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02293447
Sponsor's protocol ID: 14-8053
Status last verified: May 2016
First submitted: 10 Nov 2014
Last updated: 12 May 2016
Results posted: No
Data monitoring committee: No

Publications

Keyoung JA, Levy EB, Roth AR, Gomez-Jorge J, Chang TC, Spies JB. Intraarterial lidocaine for pain control after uterine artery embolization for leiomyomata. J Vasc Interv Radiol. 2001 Sep;12(9):1065-9. doi: 10.1016/s1051-0443(07)61592-9.
PubMed 11535769
Zhan S, Li Y, Wang G, Han H, Yang Z. Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine. Eur Radiol. 2005 Aug;15(8):1752-6. doi: 10.1007/s00330-005-2686-0. Epub 2005 Feb 5.
PubMed 15696287
Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7. doi: 10.1067/mob.2003.99.
PubMed 12548202
Pinto I, Chimeno P, Romo A, Paul L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial. Radiology. 2003 Feb;226(2):425-31. doi: 10.1148/radiol.2262011716.
PubMed 12563136
Hehenkamp WJ, Volkers NA, Donderwinkel PF, de Blok S, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol. 2005 Nov;193(5):1618-29. doi: 10.1016/j.ajog.2005.05.017.
PubMed 16260201
Hehenkamp WJ, Volkers NA, Birnie E, Reekers JA, Ankum WM. Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy--results from the randomized clinical Embolisation versus Hysterectomy (EMMY) Trial. Radiology. 2008 Mar;246(3):823-32. doi: 10.1148/radiol.2463070260. Epub 2008 Jan 9.
PubMed 18187401
Volkers NA, Hehenkamp WJ, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: 2 years' outcome from the randomized EMMY trial. Am J Obstet Gynecol. 2007 Jun;196(6):519.e1-11. doi: 10.1016/j.ajog.2007.02.029.
PubMed 17547877
Ananthakrishnan G, Murray L, Ritchie M, Murray G, Bryden F, Lassman S, Lumsden MA, Moss JG. Randomized comparison of uterine artery embolization (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): subanalysis of 5-year MRI findings. Cardiovasc Intervent Radiol. 2013 Jun;36(3):676-81. doi: 10.1007/s00270-012-0485-y. Epub 2012 Oct 16.
PubMed 23070101
Edwards RD, Moss JG, Lumsden MA, Wu O, Murray LS, Twaddle S, Murray GD; Committee of the Randomized Trial of Embolization versus Surgical Treatment for Fibroids. Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med. 2007 Jan 25;356(4):360-70. doi: 10.1056/NEJMoa062003.
PubMed 17251532
Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.
PubMed 21481151
Spencer EB, Stratil P, Mizones H. Clinical and periprocedural pain management for uterine artery embolization. Semin Intervent Radiol. 2013 Dec;30(4):354-63. doi: 10.1055/s-0033-1359729.
PubMed 24436562
Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K; Ontario Uterine Fibroid Embolization Collaboration Group. The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril. 2003 Jan;79(1):120-7. doi: 10.1016/s0015-0282(02)04538-7.
PubMed 12524074
Walker WJ, Pelage JP. Uterine artery embolisation for symptomatic fibroids: clinical results in 400 women with imaging follow up. BJOG. 2002 Nov;109(11):1262-72. doi: 10.1046/j.1471-0528.2002.01449.x.
PubMed 12452465
van der Kooij SM, Moolenaar LM, Ankum WM, Reekers JA, Mol BWJ, Hehenkamp WJK. Epidural analgesia versus patient-controlled analgesia for pain relief in uterine artery embolization for uterine fibroids: a decision analysis. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1514-1520. doi: 10.1007/s00270-013-0607-1. Epub 2013 Apr 11.
PubMed 23576212
Rasuli P, Jolly EE, Hammond I, French GJ, Preston R, Goulet S, Hamilton L, Tabib M. Superior hypogastric nerve block for pain control in outpatient uterine artery embolization. J Vasc Interv Radiol. 2004 Dec;15(12):1423-9. doi: 10.1097/01.RVI.0000137406.09852.A4.
PubMed 15590800

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Uterine Leiomyomas trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study
ClinicalTrials.gov ID: NCT02293447
Acronym / sponsor ID: 14-8053
Conditions: Uterine Leiomyomas
Keywords: Uterine, Fibroid, Embolization, Leiomyoma, Lidocaine, Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Study start: Nov 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Nov 2014 (estimated)
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.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Control	No intervention	–The control group will undergo uterine artery embolization according to regular protocol, without the administration of lidocaine.
Lidocaine per-embolization	Experimental	Drug: Lidocaine per-embolizationThis group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles.
Lidocaine post-embolization	Experimental	Drug: Lidocaine post-embolization10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation;
Patient must be able to provide written, informed consent

Key exclusion criteria (5 listed)

Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;
Personal or familial history of malignant familial hyperthermia;
Documented history of second or third atrio-ventricular heart block
Contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.
History of previous uterine fibroid embolization.

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
Lidocaine per-embolizationAlso: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 0088415410mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.	Drug	Lidocaine per-embolization
Lidocaine post-embolizationAlso: Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 0088415410mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.	Drug	Lidocaine post-embolization

Primary outcome

Post-Procedural Pain at 4 hours
Time frame: 4h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) filled by patients at 4h, 7h and 24h post-procedure. At 4h, patients will report the worst pain they experienced since end of procedure. At 7h and 24h, pain at time of assessment will be recorded.
Post-Procedural Pain at 7 hours
Time frame: 7h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)

3 secondary outcomes

Hospital length-of-stay
Time frame: 24 hours post-intervention
Narcotic dose
Time frame: 24 hours post-intervention
Post-Procedural Pain at 24 hours
Time frame: 24 hours post-procedure

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 12 May 2016.
Background: PubMed 11535769Keyoung JA, Levy EB, Roth AR, Gomez-Jorge J, Chang TC, Spies JB. Intraarterial lidocaine for pain control after uterine artery embolization for leiomyomata. J Vasc Interv Radiol. 2001 Sep;12(9):1065-9. doi: 10.1016/s1051-0443(07)61592-9.
Background: PubMed 15696287Zhan S, Li Y, Wang G, Han H, Yang Z. Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine. Eur Radiol. 2005 Aug;15(8):1752-6. doi: 10.1007/s00330-005-2686-0. Epub 2005 Feb 5.
Background: PubMed 12548202Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7. doi: 10.1067/mob.2003.99.
Background: PubMed 12563136Pinto I, Chimeno P, Romo A, Paul L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial. Radiology. 2003 Feb;226(2):425-31. doi: 10.1148/radiol.2262011716.
Background: PubMed 16260201Hehenkamp WJ, Volkers NA, Donderwinkel PF, de Blok S, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol. 2005 Nov;193(5):1618-29. doi: 10.1016/j.ajog.2005.05.017.
Background: PubMed 18187401Hehenkamp WJ, Volkers NA, Birnie E, Reekers JA, Ankum WM. Symptomatic uterine fibroids: treatment with uterine artery embolization or hysterectomy--results from the randomized clinical Embolisation versus Hysterectomy (EMMY) Trial. Radiology. 2008 Mar;246(3):823-32. doi: 10.1148/radiol.2463070260. Epub 2008 Jan 9.
Background: PubMed 17547877Volkers NA, Hehenkamp WJ, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids: 2 years' outcome from the randomized EMMY trial. Am J Obstet Gynecol. 2007 Jun;196(6):519.e1-11. doi: 10.1016/j.ajog.2007.02.029.
Background: PubMed 23070101Ananthakrishnan G, Murray L, Ritchie M, Murray G, Bryden F, Lassman S, Lumsden MA, Moss JG. Randomized comparison of uterine artery embolization (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): subanalysis of 5-year MRI findings. Cardiovasc Intervent Radiol. 2013 Jun;36(3):676-81. doi: 10.1007/s00270-012-0485-y. Epub 2012 Oct 16.
Background: PubMed 17251532Edwards RD, Moss JG, Lumsden MA, Wu O, Murray LS, Twaddle S, Murray GD; Committee of the Randomized Trial of Embolization versus Surgical Treatment for Fibroids. Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med. 2007 Jan 25;356(4):360-70. doi: 10.1056/NEJMoa062003.
Background: PubMed 21481151Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.
Background: PubMed 24436562Spencer EB, Stratil P, Mizones H. Clinical and periprocedural pain management for uterine artery embolization. Semin Intervent Radiol. 2013 Dec;30(4):354-63. doi: 10.1055/s-0033-1359729.
Background: PubMed 12524074Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K; Ontario Uterine Fibroid Embolization Collaboration Group. The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril. 2003 Jan;79(1):120-7. doi: 10.1016/s0015-0282(02)04538-7.
UHN research ethics board contact informationLink provided by the sponsor.

Related trials for Uterine Leiomyomas

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

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.

Dheeraj Rajan, MD, FRCPC principal investigator

University Health Network, Toronto

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 Lidocaine per-embolization and Lidocaine post-embolization in people with Uterine Leiomyomas, run by University Health Network, Toronto at 1 site in Canada.

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 5 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 12 May 2016. 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 Canada. 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.

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?

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?

Post-Procedural Pain at 4 hours (time frame: 4h post-procedure). The study lists 2 primary outcomes in all. 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 NCT02293447, which also lists 24 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 12 May 2016.