Total Knee Athroplasty Clinical Trial
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.
| Verified date | May 2024 |
| Source | Hospital for Special Surgery, New York |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 94 |
| Est. completion date | July 1, 2022 |
| Est. primary completion date | April 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years to 80 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital for Special Surgery | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital for Special Surgery, New York |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 24 hours Post Operative Discharge | |
| Secondary | 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. | post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. | |
| Secondary | 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. | pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months | |
| Secondary | 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 | from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months | |
| Secondary | 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. | at preoperation | |
| Secondary | 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. |
24 hours post surgical discharge. | |
| Secondary | 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. | 24 hours (POD 1) post surgical discharge. | |
| Secondary | 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. | 24 hours post operative discharge. | |
| Secondary | 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. | 24 hours post operative discharge | |
| Secondary | 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. | Pre operative, 3 months post operative discharge. | |
| Secondary | 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. |
preoperatively, 6 weeks post operative discharge, 3 months post operative discharge | |
| Secondary | 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. | at post operative day (POD) 1 | |
| Secondary | 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. | at post operative day (POD) 14 | |
| Secondary | 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. | at post operative day (POD) 90 | |
| Secondary | 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%. | at preoperation | |
| Secondary | 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%. | at post operative day (POD) 1 | |
| Secondary | 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%. | at post operative day (POD) 14 | |
| Secondary | 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%. | at post operative day (POD) 90 |