Clinical trial NCT04749615: Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Athroplasty
Keywords: TKA
PAI
ACB
IPACK
Knee Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 94
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Scores (NRS, 0-10) With Ambulation on POD1
timeFrame: 24 hours Post Operative Discharge
Secondary outcomes:
measure: Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
timeFrame: post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
measure: NRS Pain With Movement
timeFrame: pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months
measure: Numerical Rating Scale (NRS) Pain Score at Rest
timeFrame: from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
measure: PAIN OUT Questionnaire at Preoperation
timeFrame: at preoperation
measure: Quality of Recovery (POD1)
timeFrame: 24 hours post surgical discharge.
measure: Side Effects: Opioid-Related Symptom Distress Score (POD1)
timeFrame: 24 hours (POD 1) post surgical discharge.
measure: Satisfaction With Pain Management (POD1)
timeFrame: 24 hours post operative discharge.
measure: Blinding Assessment; Bang Question (POD1)
timeFrame: 24 hours post operative discharge
measure: Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
timeFrame: Pre operative, 3 months post operative discharge.
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: preoperatively, 6 weeks post operative discharge, 3 months post operative discharge
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 1
timeFrame: at post operative day (POD) 1
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 14
timeFrame: at post operative day (POD) 14
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 90
timeFrame: at post operative day (POD) 90
measure: PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
timeFrame: at preoperation
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
timeFrame: at post operative day (POD) 1
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
timeFrame: at post operative day (POD) 14
measure: PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
timeFrame: at post operative day (POD) 90
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: