Phase 3
N=119
The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
Knee Arthroplasty, Total
Bottom Line
View on ClinicalTrials.gov: NCT03703206 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery — 21.7; 45.8 percentage of patients reporting pain
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery |
21.7; 45.8 | — |
| SECONDARY Pain Score Measurement Reported by Patients |
5; 6 | — |
| SECONDARY Quality of Recovery (QoR) Score |
113; 114; 118; 123; 131; 126 | — |
Summary
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for total knee arthroplasty
- American Society Anesthesiologists (ASA) physical status I- III.
- Mentally competent and able to give consent for enrollment in the study.
Exclusion Criteria
- Patient refusal,
- allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
- Revision surgery will be excluded.
- Impaired kidney functions
- patient with coagulopathy will be also excluded.
- Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
- BMI of 45 or more
Data sourced from ClinicalTrials.gov (NCT03703206). 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.