Phase 4 N=86 Randomized Double-blind Treatment

Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

Knee Arthropathy

Bottom Line

View on ClinicalTrials.gov: NCT03094663 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Numeric Rating Scale (NRS) Pain Scores — 5.0; 1.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine with epinephrine (Drug); Methylprednisolone (Drug); Cefazolin (Drug); 8 MHz. Chiba needle (Device); Bupivacaine with Dexamethasone (Drug); Bupivacaine 25cc (Drug); Bupivacaine 20cc (Drug); Dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Numeric Rating Scale (NRS) Pain Scores	5.0; 1.7	—
SECONDARY Opioid Consumption	69.1; 40.6	—
SECONDARY Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement	3.4; 1.2	—
SECONDARY Ambulation Distance During Physical Therapy	23.2; 25.7; 81.1; 87.7; 112; 116.7	—
SECONDARY Level of Patient Satisfaction With Postoperative Pain Management	8.8; 9.5	—
SECONDARY Pain Outcomes	6.9; 5.6	—
SECONDARY Hospital Length of Stay	2991; 3081	—
SECONDARY Opioid Related Symptom Distress Scale (ORSDS)	0.4; 0.3; 0.5; 0.4	—
SECONDARY Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)	54; 52; 73; 77	—

Summary

A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Eligibility Criteria

Inclusion Criteria

Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
Age 18 to 80 years
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (secondary outcomes include questionnaires validated in English only)
Patients of participating surgeons

Exclusion Criteria

Hepatic or renal insufficiency
Younger than 18 years old and older than 80
Patients undergoing general anesthesia
Allergy or intolerance to one of the study medications
BMI > 40
Diabetes
ASA of IV
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
Patients with severe valgus deformity and flexion contracture

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03094663). 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.