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Completed

NCT Number: NCT04749615

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

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. The main question it aims to answer is:

• 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.

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Key information

Conditions

Total Knee Athroplasty

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • 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)

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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

    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.

  3. 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

    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

  4. PAIN OUT Questionnaire at Preoperation

    Time frame: 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.

  5. Quality of Recovery (POD1)

    Time frame: 24 hours post surgical discharge.

    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.

  6. Side Effects: Opioid-Related Symptom Distress Score (POD1)

    Time frame: 24 hours (POD 1) post surgical discharge.

    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.

  7. Satisfaction With Pain Management (POD1)

    Time frame: 24 hours post operative discharge.

    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.

  8. Blinding Assessment; Bang Question (POD1)

    Time frame: 24 hours post operative discharge

    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.

  9. Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months

    Time frame: Pre operative, 3 months post operative discharge.

    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.

  10. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

    Time frame: preoperatively, 6 weeks post operative discharge, 3 months post operative discharge

    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.

  11. PAIN OUT Questionnaire at Post Operative Day (POD) 1

    Time frame: 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.

  12. PAIN OUT Questionnaire at Post Operative Day (POD) 14

    Time frame: 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.

  13. PAIN OUT Questionnaire at Post Operative Day (POD) 90

    Time frame: 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.

  14. PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief

    Time frame: 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. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.

  15. 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

    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%.

  16. 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

    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%.

  17. 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

    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%.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.