Hip ArthropathyNCT03801863
The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace
An observational study of Hip Arthropathy and Regional Anesthesia, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Arthropathy, Regional Anesthesia
- What is being tested?
- Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375% and Ropivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 26 Jan 2022
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing primary total hip replacement under neuraxial anesthesia
Who may be able to join
- Patients undergoing primary hip arthroplasty
- American Society of Anesthesiologists (ASA) Category 1, 2, and 3
- Patients age ≥18 years
Who cannot join
- Patient refusal
- Inability to understand and sign consent
- Infection at the injection site
- Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
- Contraindication or patient refusal to get spinal anesthesia
- Thrombocytopenia (platelets < 100,000)
Show all 9Show fewer
- Coagulopathy (INR > 1.4)
- Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery
- ASA Category 4 and 5
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center- Wakefield Campus
The Bronx, New York, 10467
About this study
Official title: The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace- a Randomized Controlled Study Comparing the 24-hour Opioid Requirements.
Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.2 Moreover; optimal pain management can reduce the duration of hospitalization and the risk of adverse events, such as deep vein thrombus. The use of regional anesthesia reduces the postoperative opioid requirement, thereby decreasing the degree to which patients suffer the side effects of opioids, namely sedation and constipation, and less frequently nausea, vomiting, respiratory depression, pruritus, and retention. In the past, femoral nerve block, fascia iliaca compartment block, lumbar plexus block and the quadratus lumborum block have been shown efficacious for pain relief for hip arthroplasty. However there are several risk factors such as quadricep weakness and difficulty of the block that causes a limitation in the used of this blocks. Recently, the erector spinae plane block has been introduced as an alternative to the blocks above. This block was first described in the literature in 2016 when it was used to treat chronic neuropathic thoracic pain. Since then, there have been studies demonstrating its efficacy with a thoracic approach for analgesia in breast surgery and rib fractures.9 Only two case reports to date have demonstrated a lumbar approach to achieve analgesia for hip arthroplasty.10,11 The purpose of the study is to determine whether or not a lumbar erector spinae plane block is effective at improving postoperative pain in patients receiving hip arthroplasty.
Read the detailed description
Hypothesis:
The erector spinae plane block will decrease opioid requirements in patients undergoing hip arthroplasty as compared to patients that do not receive the block.
Primary Objective:
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
Secondary Endpoints:
To evaluate the pain scores at discharge from PACU, at 2 hours post PACU discharge, at 24 hours and at 48 hours postoperative; to evaluate the sensory distribution of the block (T10-L5); to evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness
Design and methods This is a randomized, prospective study in patients receiving hip arthroplasty. Patients will be assigned to receive a lumbar erector spinae block versus no block. There will be no change in the primary anesthetic technique (spinal anesthesia with sedation) since these patients routinely get spinal anesthesia for hip arthroplasty. Consent for the study will be obtained in the preoperative area upon arrival for surgery. Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. Patients to receive a nerve block will receive mild sedation (1-2mg midazolam ± ≤100mcg fentanyl). All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.
Postoperatively, the PACU nurse will be asked to document pain scores according to the Visual Analog Scale (VAS) and total dose of opioids given. The distribution of the sensory block and motor weakness will be documented in the anesthesiologist's PACU discharge note. For patients that receive the block, the Physical therapist note will be assessed for any report of quadriceps muscle weakness (i.e., evidence of buckling while walking).
For postoperative data collection, opioid consumption totals and the pain scores at 2 hours post admission, at 24 hours and 48 hours post-procedure will be collected from the electronic medical record (EMR) as documented by nurses on the admitting floor. Additionally, the Acute Pain service, who rounds on all patients that receive nerve blocks, will make a note of the pain scores of the patient and any residual muscle weakness or decreased sensation at 24- and 48-hours post-procedure. All data will then be extracted from the EMR by the research assistant.
- Conditions
- Hip Arthropathy, Regional Anesthesia
- Being tested
- Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%, Ropivacaine
- Keywords
- Erector Spinae Plane Block, Ropivacaine, Ultrasound guided nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%Procedure or surgery
Ultrasound-guided Erector Spinae Plane Block will be done at L4 interspace. Ropivacaine 0.375% will be used.
RopivacaineDrug
Using 0.375% Ropivacaine in the nerve block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Erector Spinae Block | Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally. Receives: Procedure: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%; Drug: Ropivacaine | |
| No Ultrasound-guided Erector Spinae Block | Patients with no peripheral nerve block to serve as the control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in PACU and 24 hours post surgery
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
Measured: 24 hours
Secondary outcomes (5)
Pain scores at 2 hours post PACU discharge
To evaluate the pain scores at 2 hours post PACU discharge
Measured: 2 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
To evaluate the sensory distribution of the block (T10-L5).
Will test for temperature difference using ice cube.
Measured: 2 hours post-surgery
To evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness
Will have patient walk and Physical Therapist will assess for buckling of knee or potential falls while ambulating.
Measured: 30 hours post-surgery
Pain scores at 24 hours post PACU discharge
To evaluate the pain scores at 24 hours post PACU discharge
Measured: 24 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
Pain scores at 48 hours postoperative
To evaluate the pain scores at 48 hours postoperative.
Measured: 48 hours post-surgery. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Mar 2019
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Why it stopped: Study "Administratively closed" by Albert Einstein College of Medicine IRB as approval expired. PI no longer with institution. IRB approval expiry date used as Primary Completion date and Study Completion Date. Enrollment total derived from CTMS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iyabo Muse, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801863
- Sponsor's protocol ID
- 2018-9687
- Status last verified
- Jul 2023
- First submitted
- 5 Jan 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8.
PubMed 25714040Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.
PubMed 30092937Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
PubMed 29149734Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
PubMed 29522966Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.
PubMed 19309064
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace- a Randomized Controlled Study Comparing the 24-hour Opioid Requirements.
- ClinicalTrials.gov ID
- NCT03801863
- Acronym / sponsor ID
- 2018-9687
- Conditions
- Hip Arthropathy, Regional Anesthesia
- Keywords
- Erector Spinae Plane Block, Ropivacaine, Ultrasound guided nerve block
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study "Administratively closed" by Albert Einstein College of Medicine IRB as approval expired. PI no longer with institution. IRB approval expiry date used as Primary Completion date and Study Completion Date. Enrollment total derived from CTMS
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 14 Jan 2019 (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.
Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.2 Moreover; optimal pain management can reduce the duration of hospitalization and the risk of adverse events, such as deep vein thrombus. The use of regional anesthesia reduces the postoperative opioid requirement, thereby decreasing the degree to which patients suffer the side effects of opioids, namely sedation and constipation, and less frequently nausea, vomiting, respiratory depression, pruritus, and retention. In the past, femoral nerve block, fascia iliaca compartment block, lumbar plexus block and the quadratus lumborum block have been shown efficacious for pain relief for hip arthroplasty. However there are several risk factors such as quadricep weakness and difficulty of the block that causes a limitation in the used of this blocks. Recently, the erector spinae plane block has been introduced as an alternative to the blocks above. This block was first described in the literature in 2016 when it was used to treat chronic neuropathic thoracic pain. Since then, there have been studies demonstrating its efficacy with a thoracic approach for analgesia in breast surgery and rib fractures.9 Only two case reports to date have demonstrated a lumbar approach to achieve analgesia for hip arthroplasty.10,11 The purpose of the study is to determine whether or not a lumbar erector spinae plane block is effective at improving postoperative pain in patients receiving hip arthroplasty.
Detailed description
Hypothesis:
The erector spinae plane block will decrease opioid requirements in patients undergoing hip arthroplasty as compared to patients that do not receive the block.
Primary Objective:
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
Secondary Endpoints:
To evaluate the pain scores at discharge from PACU, at 2 hours post PACU discharge, at 24 hours and at 48 hours postoperative; to evaluate the sensory distribution of the block (T10-L5); to evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness
Design and methods This is a randomized, prospective study in patients receiving hip arthroplasty. Patients will be assigned to receive a lumbar erector spinae block versus no block. There will be no change in the primary anesthetic technique (spinal anesthesia with sedation) since these patients routinely get spinal anesthesia for hip arthroplasty. Consent for the study will be obtained in the preoperative area upon arrival for surgery. Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. Patients to receive a nerve block will receive mild sedation (1-2mg midazolam ± ≤100mcg fentanyl). All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.
Postoperatively, the PACU nurse will be asked to document pain scores according to the Visual Analog Scale (VAS) and total dose of opioids given. The distribution of the sensory block and motor weakness will be documented in the anesthesiologist's PACU discharge note. For patients that receive the block, the Physical therapist note will be assessed for any report of quadriceps muscle weakness (i.e., evidence of buckling while walking).
For postoperative data collection, opioid consumption totals and the pain scores at 2 hours post admission, at 24 hours and 48 hours post-procedure will be collected from the electronic medical record (EMR) as documented by nurses on the admitting floor. Additionally, the Acute Pain service, who rounds on all patients that receive nerve blocks, will make a note of the pain scores of the patient and any residual muscle weakness or decreased sensation at 24- and 48-hours post-procedure. All data will then be extracted from the EMR by the research assistant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Erector Spinae Block | – | Procedure: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%, Drug: RopivacainePatients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally. |
| No Ultrasound-guided Erector Spinae Block | – | –Patients with no peripheral nerve block to serve as the control. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary total hip replacement under neuraxial anesthesia
Key inclusion criteria (3 listed)
- Patients undergoing primary hip arthroplasty
- American Society of Anesthesiologists (ASA) Category 1, 2, and 3
- Patients age ≥18 years
Key exclusion criteria (9 listed)
- Patient refusal
- Inability to understand and sign consent
- Infection at the injection site
- Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
- Contraindication or patient refusal to get spinal anesthesia
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 |
|---|---|---|
| Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%Ultrasound-guided Erector Spinae Plane Block will be done at L4 interspace. Ropivacaine 0.375% will be used. | Procedure or surgery | Ultrasound-guided Erector Spinae Block |
| RopivacaineUsing 0.375% Ropivacaine in the nerve block | Drug | Ultrasound-guided Erector Spinae Block |
Primary outcome
Opioid Consumption in PACU and 24 hours post surgery
Time frame: 24 hours
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
5 secondary outcomes
Pain scores at 2 hours post PACU discharge
Time frame: 2 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
To evaluate the sensory distribution of the block (T10-L5).
Time frame: 2 hours post-surgery
To evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness
Time frame: 30 hours post-surgery
Pain scores at 24 hours post PACU discharge
Time frame: 24 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
Pain scores at 48 hours postoperative
Time frame: 48 hours post-surgery. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain
Results and safety
The study was stopped early (reason given: Study "Administratively closed" by Albert Einstein College of Medicine IRB as approval expired. PI no longer with institution. IRB approval expiry date used as Primary Completion date and Study Completion Date. Enrollment total derived from CTMS). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Background: PubMed 25714040Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8.
- Background: PubMed 30092937Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.
- Background: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- Background: PubMed 29149734Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
- Background: PubMed 29522966Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
- Background: PubMed 19309064Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.
- 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.
Iyabo Muse, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Regional Anesthesia, run by Montefiore Medical Center at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Jul 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 United States. 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 was stopped early (reason given: Study "Administratively closed" by Albert Einstein College of Medicine IRB as approval expired. PI no longer with institution. IRB approval expiry date used as Primary Completion date and Study Completion Date. Enrollment total derived from CTMS). Results are not available in the source record.
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?
Opioid Consumption in PACU and 24 hours post surgery (time frame: 24 hours). 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 NCT03801863, which also lists 6 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 21 Jul 2023.