Implementation of a Pain Management Protocol for Total Knee Arthroplasty

Knee Replacement, Total Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474654
• Other study ID #: 15-009
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: January 14, 2019

Study information

• Verified date: January 2019
• Source: Health Sciences North Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Replacement, Total

Intervention

Drug:
• Bupivicaine
15mg
• Fentanyl
15mcg
• Epimorphine
150mcg
• Normal Saline
0.3 ml
• Normal Saline
30ml
• Normal Saline
100 ml
• Ropivicaine
100 ml
• Epinephrine
600 mcg
• Ketorolac
30 mg
• Ropivicaine with Epinephrine
0.5% 1:400,000 30ml

Locations

Country	Name	City	State
Canada	Health Sciences North Research Institute	Sudbury	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Health Sciences North Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Discharge	Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day 1 to discharge date or day 5
Secondary	Time up and go performance measures	Measured by physiotherapists - Functional Outcome - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day1 to discharge date or day 5
Secondary	Total Opioid Consumption Measures	Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day 0 to discharge date or day 5
Secondary	Complications	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	Post-op day 0 to discharge date or day 5