Clinical trial NCT02474654: Implementation of a Pain Management Protocol for Total Knee Arthroplasty
Official title: An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Replacement, Total
Lead sponsor: Health Sciences North Research Institute
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?

Detailed description: Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required.

Specific 5 arms include:

* Using all three anesthetics:

  o PI + FB + IO (arm 1)
* Using a combination of two anesthetics + normal saline substitute for control:

  * NS + FB + IO (arm 2)
  * PI + NS + IO (arm 3)
  * PI + FB + NS (arm 4)
* Control:

  * NS + NS + IO (arm 5)

The control arm would include IO as the sole intervention as this is simply added to the spinal anesthetic used for the surgery itself. It is felt that having a study arm without any long-acting analgesic medication (opioid or local anesthetic) as the "control" arm following a spinal anesthetic would not meet current standard of care and cause harm to the participant

The investigators hypothesize that the combination of three forms of long acting analgesia (PI, FB, IO) will result in the greatest outcomes compared to a combination of any two or control. Our aim is to demonstrate that this optimal analgesic combination will have an additive pain control effect and will minimize side effects thus translating to less acute pain, improve patient mobility, and attaining "readiness to discharge" quicker.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* primary total knee replacement for osteoarthritis
* agrees to a spinal anesthetic for TKR

Exclusion Criteria:

* History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month)
* general anesthetic for TKR
* major neurological deficit
* allergy to local anesthetic
* allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
* renal insufficiency
* liver failure

Primary outcomes:
measure: Time to Discharge
timeFrame: Post-op day 1 to discharge date or day 5
Secondary outcomes:
measure: Time up and go performance measures
timeFrame: Post-op day1 to discharge date or day 5
measure: Total Opioid Consumption Measures
timeFrame: Post-op day 0 to discharge date or day 5
measure: Complications
timeFrame: Post-op day 0 to discharge date or day 5
Other outcomes:
Locations:
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute
state: Ontario
Study officials:
affiliation: Health Sciences North
name: Kim Wong, MD, FRCPC, BSc, PT
role: PRINCIPAL_INVESTIGATOR
References: