Implementation of a Pain Management Protocol for Total Knee Arthroplasty

NCT02474654 | Completed Phase 4

• 1 other identifier: 15-009
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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)?

Conditions

Knee Replacement, Total

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time up and go performance measures

  Post-op day1 to discharge date or day 5

• Total Opioid Consumption Measures

  Post-op day 0 to discharge date or day 5

• Complications

  Post-op day 0 to discharge date or day 5

Study Arms (5)

Arm 1: PI+FNB+IO

EXPERIMENTAL

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

Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Ropivicaine with Epinephrine

Arm 2:NS+FNB+IO

EXPERIMENTAL

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml

Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline; Drug: Ropivicaine with Epinephrine

Arm 3: PI+NS+IO

EXPERIMENTAL

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg

Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac

Arm 4: PI+FNB+NS

EXPERIMENTAL

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

Drug: Bupivicaine; Drug: Fentanyl; Drug: Normal Saline; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Ropivicaine with Epinephrine

Arm 5:NS+NS+IO

ACTIVE COMPARATOR

Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml

Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline

Interventions

Bupivicaine DRUG

15mg

Arm 1: PI+FNB+IO; Arm 2:NS+FNB+IO; Arm 3: PI+NS+IO; Arm 4: PI+FNB+NS; Arm 5:NS+NS+IO

Fentanyl DRUG

15mcg

Arm 1: PI+FNB+IO; Arm 2:NS+FNB+IO; Arm 3: PI+NS+IO; Arm 4: PI+FNB+NS; Arm 5:NS+NS+IO

Epimorphine DRUG

150mcg

Arm 1: PI+FNB+IO; Arm 2:NS+FNB+IO; Arm 3: PI+NS+IO; Arm 5:NS+NS+IO

Normal Saline DRUG

0.3 ml

Arm 4: PI+FNB+NS

Ropivicaine DRUG

100 ml

Arm 1: PI+FNB+IO; Arm 3: PI+NS+IO; Arm 4: PI+FNB+NS

Epinephrine DRUG

600 mcg

Arm 1: PI+FNB+IO; Arm 3: PI+NS+IO; Arm 4: PI+FNB+NS

Ketorolac DRUG

30 mg

Arm 1: PI+FNB+IO; Arm 3: PI+NS+IO; Arm 4: PI+FNB+NS

Ropivicaine with Epinephrine DRUG

0.5% 1:400,000 30ml

Arm 1: PI+FNB+IO; Arm 2:NS+FNB+IO; Arm 4: PI+FNB+NS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Sciences North Research Institute: lead

Study Sites (1)

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

MeSH Terms

Interventions

Fentanyl; Saline Solution; Epinephrine; Ketorolac

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kim Wong, MD, FRCPC, BSc, PT

  Health Sciences North

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2015
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

CA (1)