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Completed

NCT Number: NCT02474654

Implementation of a Pain Management Protocol for Total Knee Arthroplasty

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)?

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Key information

Conditions

Knee Replacement, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupivicaine

Drug

15mg

Fentanyl

Drug

15mcg

Epimorphine

Drug

150mcg

normal saline

Drug

0.3 ml

ropivicaine

Drug

100 ml

Epinephrine

Drug

600 mcg

Ketorolac

Drug

30 mg

Ropivicaine with Epinephrine

Drug

0.5% 1:400,000 30ml

Primary outcomes

  1. Time to Discharge

    Time frame: Post-op day 1 to discharge date or day 5

    Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days

Secondary outcomes

  1. Time up and go performance measures

    Time frame: Post-op day1 to discharge date or day 5

    Measured by physiotherapists - Functional Outcome - Participants will be followed for the duration of hospital stay, approximately 3-5 days

  2. Total Opioid Consumption Measures

    Time frame: Post-op day 0 to discharge date or day 5

    Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days

  3. Complications

    Time frame: Post-op day 0 to discharge date or day 5

    To include nausea, vomiting, pruritis as assessed by Common Terminology Criteria for Adverse Events (CTCAE) - Participants will be followed for the duration of hospital stay, approximately 3-5 days

Sponsors and collaborators

Lead sponsor

Health Sciences North Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2015
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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