The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: 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)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital for Special Surgery, New York Overall contact: Jennifer Cheng, PhD, Phone: 212-774-7377, Email: ChengJ@hss.edu
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.
Clinical Details
Official title: The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Time to Meet Physical Therapy Discharge Criteria
Secondary outcome: Numerial Rating Scale (NRS) Pain ScoresOpioid Consumption Hospital Length of Stay Patient Outcome Questionnaire (painOUT) Knee Society Score (KSS)
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Jennifer Cheng, PhD, Phone: 212-774-7377, Email: ChengJ@hss.edu
Hospital for Special Surgery, New York, New York 10021, United States; Recruiting Enrique Goytizolo, MD, Phone: 212-606-1036, Email: GoytizoloE@hss.edu Sumudu Dehipawala, BS, Phone: 646-797-8536, Email: DehipawalaS@hss.edu Enrique Goytizolo, MD, Principal Investigator
Additional Information
Starting date: November 2014
Last updated: March 31, 2015
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