Phase 4 N=111 Randomized Double-blind Treatment

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT02292082 ↗

Enrolled (actual)

111

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcome: Primary: Time to Meet Physical Therapy Discharge Criteria — 2109.3; 1883.1 Minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine (Drug); Morphine (Drug); Methylprednisolone (Drug); Cefazolin (Drug); Normal saline (Drug); Midazolam (Drug); Propofol (Drug); Dexamethasone (Drug); 8 MHz. Chiba needle, 22 G / 4 inches (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Meet Physical Therapy Discharge Criteria	2109.3; 1883.1	—
SECONDARY Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1	4.3; 3.9	—
SECONDARY NRS Pain Score With Movement POD2	4.7; 5.2	—
SECONDARY Opioid Consumption Postoperative Day (POD) 1	58.4; 47.5	—
SECONDARY Opioid Consumption POD2	67.9; 60.1	—
SECONDARY Hospital Length of Stay	3491; 3394.4	—
SECONDARY Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively	1.5; 0.8	—
SECONDARY Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively	1.7; 1.8	—
SECONDARY Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively	6.7; 5.3	—
SECONDARY Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively	6.9; 6.6	—
SECONDARY Knee Society Score (KSS) at 6 Weeks Postoperatively	85.2; 75.2	—

Summary

Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

Eligibility Criteria

Inclusion Criteria

Patients with osteoarthritis scheduled for primary tricompartmental 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)

Exclusion Criteria

Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02292082). 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.