Phase 4 N=94 Randomized Triple-blind Supportive Care

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

Total Knee Athroplasty

Bottom Line

View on ClinicalTrials.gov: NCT04749615 ↗

Enrolled (actual)

Serious AEs

3.2%

Results posted

Jun 2024

Primary outcome: Primary: Pain Scores (NRS, 0-10) With Ambulation on POD1 — 4.55; 4.26 units on a scale — p=0.11

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Periarticular Injection (PAI) (Drug); Saline Control Periarticular Injection (PAI) (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores (NRS, 0-10) With Ambulation on POD1	4.55; 4.26	0.11
SECONDARY Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)	25.45; 21.98; 25.95; 22.16; 37.3; 28.64	0.5
SECONDARY NRS Pain With Movement	5.17; 5.85; 5.7; 5.19; 4.55; 4.26	—
SECONDARY Numerical Rating Scale (NRS) Pain Score at Rest	1.19; 1.79; 5.66; 5.06; 2.36; 2.47	—
SECONDARY PAIN OUT Questionnaire at Preoperation	0.96; 1.45; 6.57; 6.79; 3.11; 3.02	—
SECONDARY Quality of Recovery (POD1)	16.62; 16.96	—
SECONDARY Side Effects: Opioid-Related Symptom Distress Score (POD1)	.55; .74	—
SECONDARY Satisfaction With Pain Management (POD1)	9.7; 9.66	—
SECONDARY Blinding Assessment; Bang Question (POD1)	10; 8; 13; 17; 24; 22	—
SECONDARY Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months	2.79; 2.62; 2.63; 2.78	—
SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement	50.7; 49.61; 78.31; 77.05; 83.39; 83.60	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 1	1.17; 1.34; 6.53; 6.15; 2.32; 2.4	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 14	1.72; 1.54; 5.6; 5.26; 2.68; 2.09	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 90	.05; .24; 1.68; 1.81; .29; .89	—
SECONDARY PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief	17.02; 18.09; 5.5; 6.14	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief	12.55; 11.49; 9.93; 10.14	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief	14.47; 17.61; 9.65; 9.5	—
SECONDARY PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief	9.02; 7.57; 10.12; 10.37	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04749615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.