Clinical trial NCT02292082: The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Official title: The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Nerve Block
Rehabilitation
Knee Replacement, Total
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.

Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.

Time to reach discharge criteria based on physical therapy assessments will also be measured.

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

Primary outcomes:
measure: Time to Meet Physical Therapy Discharge Criteria
timeFrame: First 3 days post-operatively
Secondary outcomes:
measure: Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
timeFrame: 24 hours after operating room discharge
measure: NRS Pain Score With Movement POD2
timeFrame: 48 hours after surgery
measure: Opioid Consumption Postoperative Day (POD) 1
timeFrame: 0-24 hours postoperatively
measure: Opioid Consumption POD2
timeFrame: 24-48 hours postoperative
measure: Hospital Length of Stay
timeFrame: Average of 3 days
measure: Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
timeFrame: Participants will be followed for the duration of 2 days post operatively in the hospital
measure: Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
timeFrame: 24-48 hours postoperative
measure: Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
timeFrame: 0-24 hours postoperatively
measure: Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
timeFrame: 24-48 hours postoperative
measure: Knee Society Score (KSS) at 6 Weeks Postoperatively
timeFrame: Post operatively at approximately 6 weeks after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Enrique A Goytizolo, MD
role: PRINCIPAL_INVESTIGATOR
References: