Total Knee AthroplastyPhase 4NCT04749615

Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?

A Phase 4 study testing Periarticular Injection (PAI) in people with Total Knee Athroplasty, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

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

Official record

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Trial summary

The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. Read more about this study

Who is it for?: Ages 25 to 80 years
Conditions the study is for: Total Knee Athroplasty
What is being tested?: Periarticular Injection (PAI)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2020to 1 Jul 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned use of regional anesthesia
Ability to follow the major components of the study protocol
English speaking (Secondary outcomes include questionnaires validated in English only)

Who cannot join

Patients younger than 25 years old and older than 80
Non-English speaking
Patients intending to receive general anesthesia
Contraindication to nerve blocks or peri-articular injection
Patients with an ASA of IV or higher
Renal insufficiency (ESRD, HD, estimated creatinine clearance < 30 ml/min)

Show all 9Show fewer

Patients with major prior ipsilateral open knee surgery
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Official title: Does Periarticular Injection (PAI) Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving Adductor Canal Block and Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (ACB&IPACK)? A Blinded, Randomized Controlled Trial.

Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?

Participants will be assigned to one of the following groups at random:

ACB/PACK with PAI
ACB/IPACK with saline injection

Participants will also be asked to complete pre- and post-operative questionnaires.

Read the detailed description

Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents).

It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not, without obvious large differences in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in addition to ACB/IPACK, it is not desirable to perform unnecessary procedures.

In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.

Conditions: Total Knee Athroplasty
Being tested: Periarticular Injection (PAI), Saline Control Periarticular Injection (PAI)
Keywords: TKA, PAI, ACB, IPACK, Knee Arthroplasty

What participants receive

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

Periarticular Injection (PAI)Drug
PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
Saline Control Periarticular Injection (PAI)Drug
equal volume of saline will be used in place of analgesics used in PAI injections

Study groups in NCT04749615
Study group	Role	What they receive
No PAI + ACB & IPACK	Placebo comparator	Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline) Receives: Drug: Saline Control Periarticular Injection (PAI)
PAI + ACB & IPACK	Active comparator	Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine Receives: Drug: Periarticular Injection (PAI)

What is being measured

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

Pain Scores (NRS, 0-10) With Ambulation on POD1
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.
Measured: 24 hours Post Operative Discharge

Secondary outcomes (17)

Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
Measured: post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
NRS Pain With Movement
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months.
Measured: pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months
Numerical Rating Scale (NRS) Pain Score at Rest
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
Measured: from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
PAIN OUT Questionnaire at Preoperation
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Measured: at preoperation
Quality of Recovery (POD1)
Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time).
The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia.
The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge.
Measured: 24 hours post surgical discharge.
Side Effects: Opioid-Related Symptom Distress Score (POD1)
The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge.
Measured: 24 hours (POD 1) post surgical discharge.
Satisfaction With Pain Management (POD1)
This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge.
Measured: 24 hours post operative discharge.
Blinding Assessment; Bang Question (POD1)
There is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge.
Measured: 24 hours post operative discharge
Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point.
Measured: Pre operative, 3 months post operative discharge.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively.
KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge.
Measured: preoperatively, 6 weeks post operative discharge, 3 months post operative discharge
PAIN OUT Questionnaire at Post Operative Day (POD) 1
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Measured: at post operative day (POD) 1
PAIN OUT Questionnaire at Post Operative Day (POD) 14
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Measured: at post operative day (POD) 14
PAIN OUT Questionnaire at Post Operative Day (POD) 90
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Measured: at post operative day (POD) 90
PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Measured: at preoperation
PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Measured: at post operative day (POD) 1
PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Measured: at post operative day (POD) 14
PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Measured: at post operative day (POD) 90

Timeline

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

17 Dec 20201 Jul 2022

First posted11 Feb 2021
Study start17 Dec 2020
Primary completion1 Apr 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Total Knee AthroplastyStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe 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
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04749615
Sponsor's protocol ID: 2019-2096
Status last verified: May 2024
First submitted: 5 Feb 2021
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Periarticular Injection (PAI) Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving Adductor Canal Block and Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (ACB&IPACK)? A Blinded, Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT04749615
Acronym / sponsor ID: 2019-2096
Conditions: Total Knee Athroplasty
Keywords: TKA, PAI, ACB, IPACK, Knee Arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 17 Dec 2020 (actual)
Primary completion: 1 Apr 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 11 Feb 2021 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?

Participants will be assigned to one of the following groups at random:

ACB/PACK with PAI
ACB/IPACK with saline injection

Participants will also be asked to complete pre- and post-operative questionnaires.

Detailed description

In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
No PAI + ACB & IPACK	Placebo comparator	Drug: Saline Control Periarticular Injection (PAI)Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
PAI + ACB & IPACK	Active comparator	Drug: Periarticular Injection (PAI)Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine

Who may qualify

Ages: 25 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Planned use of regional anesthesia
Ability to follow the major components of the study protocol
English speaking (Secondary outcomes include questionnaires validated in English only)

Key exclusion criteria (9 listed)

Patients younger than 25 years old and older than 80
Non-English speaking
Patients intending to receive general anesthesia
Contraindication to nerve blocks or peri-articular injection
Patients with an ASA of IV or higher

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
Periarticular Injection (PAI)PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.	Drug	PAI + ACB & IPACK
Saline Control Periarticular Injection (PAI)equal volume of saline will be used in place of analgesics used in PAI injections	Drug	No PAI + ACB & IPACK

Primary outcome

Pain Scores (NRS, 0-10) With Ambulation on POD1
Time frame: 24 hours Post Operative Discharge
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.

17 secondary outcomes

Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
Time frame: post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
NRS Pain With Movement
Time frame: pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months
Numerical Rating Scale (NRS) Pain Score at Rest
Time frame: from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
PAIN OUT Questionnaire at Preoperation
Time frame: at preoperation
Quality of Recovery (POD1)
Time frame: 24 hours post surgical discharge.
Side Effects: Opioid-Related Symptom Distress Score (POD1)
Time frame: 24 hours (POD 1) post surgical discharge.
Satisfaction With Pain Management (POD1)
Time frame: 24 hours post operative discharge.
Blinding Assessment; Bang Question (POD1)
Time frame: 24 hours post operative discharge
Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
Time frame: Pre operative, 3 months post operative discharge.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Time frame: preoperatively, 6 weeks post operative discharge, 3 months post operative discharge
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Time frame: at post operative day (POD) 1
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Time frame: at post operative day (POD) 14
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Time frame: at post operative day (POD) 90
PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
Time frame: at preoperation
PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
Time frame: at post operative day (POD) 1
PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
Time frame: at post operative day (POD) 14
PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
Time frame: at post operative day (POD) 90

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No PAI + ACB & IPACK	47	41
PAI + ACB & IPACK	47	37

Primary outcome: Pain Scores (NRS, 0-10) With Ambulation on POD1

Time frame: 24 hours Post Operative Discharge. Mean (Standard Deviation). Unit: units on a scale

Measure	No PAI + ACB & IPACK n = 47	PAI + ACB & IPACK n = 47
Value	4.55 (2.7)	4.26 (3.03)

No PAI + ACB & IPACK vs PAI + ACB & IPACK: p = 0.11, t-test, 1 sided

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No PAI + ACB & IPACK	1 of 47 (2.1%)	0 of 47 (0%)	0 of 47
PAI + ACB & IPACK	2 of 47 (4.3%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).

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.

Jacques YaDeau, MD, PhD principal investigator

Hospital for Special Surgery, New York

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 Periarticular Injection (PAI) in people with Total Knee Athroplasty, run by Hospital for Special Surgery, New York 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: finished, as of the sponsor's last update on 27 Dec 2024. 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. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Scores (NRS, 0-10) With Ambulation on POD1 (time frame: 24 hours Post Operative Discharge). 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 NCT04749615.

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 27 Dec 2024.