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Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Terminated
CT.gov ID
NCT02570503
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
64.4
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.

Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.

All patients will also receive a long-acting (24 hours) morphine injection during surgery.

The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Data Collection:

Data will be collected from the patient's medical record after discharge

Variables include:

  • Age

  • Sex

  • BMI

  • UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit

  • Patient's assessment of acceptability of pain

  • UPAT score as assessed by physical therapy pre and post therapy sessions

  • Duramorph dose

  • Time patient arrived on the Orthopedic Unit

  • Length of ambulation during physical therapy sessions

  • Amount of supplementary opioids (measured in morphine equivalents)

  • Use of anti-emetics

  • Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event

  • Length of hospital stay

The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Feb 11, 2021
Actual Study Completion Date :
Feb 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ROP/KET/CLON/EPI/SAL

Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml

Drug: Ropivacaine
Ropivacaine (5mg/ml)-50ml
Other Names:
  • periarticular injection

    • Drug: Ketorolac
    ketorolac (30mg/ml)- 1 ml
    Other Names:
  • periarticular injection

    • Drug: Clonidine
    clonidine (0.1mg/ml)- 0.8ml
    Other Names:
  • periarticular injection

    • Drug: Epinephrine
    epinephrine (1mg/ml)-1ml
    Other Names:
  • periarticular injection

    • Drug: 0.9% sodium chloride
    Sodium chloride 0.9%- 47.7 ml
    Other Names:
  • periarticular injection

    		•
    Placebo Comparator: Placebo

    0.9% Sodium Chloride- 100ml

    Drug: 0.9% sodium chloride
    Sodium chloride 0.9%- 47.7 ml
    Other Names:
  • periarticular injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Universal Pain Assessment Tool (UPAT) [3 days after surgery]

      Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.

    2. Narcotic Use During Hospitalization [0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period]

      The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.

    Secondary Outcome Measures

    1. Patient's Subjective Rating of Pain [3 days after surgery]

      Patients are asked if their pain is acceptable (yes/no)

    2. UPAT Score Before and After Physical Therapy [3 days after surgery]

      Pain in score change after physical therapy

    3. Ambulation During Physical Therapy [48 hours after surgery]

      The length (in feet) patient is able to ambulate during physical therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age 18 or older

    • Written informed consent

    Exclusion Criteria:

    • Pregnant women

    • Creatinine clearance less than 60 ml/min

    • BMI greater than 40

    • Currently use greater than 80mg morphine-equivalents daily (pre-operatively)

    • Receive a unicondylar knee replacement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Gregory Golladay, MD, Virginia Commonwealth University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT02570503
    Other Study ID Numbers:
    • HM20004125
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Pain, Postoperative
    Ketorolac
    Clonidine
    Epinephrine
    Ropivacaine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Period Title: Overall Study
    STARTED 34 30
    COMPLETED 34 30
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo Total
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml Total of all reporting groups
    Overall Participants 34 30 64
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.0
    (8.1)
    64.1
    (9.4)
    64.6
    (8.6)
    Sex: Female, Male (Count of Participants)
    Female
    15
    44.1%
    16
    53.3%
    31
    48.4%
    Male
    19
    55.9%
    14
    46.7%
    33
    51.6%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    34
    100%
    30
    100%
    64
    100%

    Outcome Measures

    1. Primary Outcome
    Title Universal Pain Assessment Tool (UPAT)
    Description Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
    Time Frame 3 days after surgery

    Outcome Measure Data

    Analysis Population Description
    Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Measure Participants 0 0
    2. Primary Outcome
    Title Narcotic Use During Hospitalization
    Description The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
    Time Frame 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Measure Participants 34 30
    0 to 24 hour post surgery period
    58.9
    (41.2)
    72.3
    (49.4)
    24 to 48 hour post surgery period
    66.5
    (51.3)
    72.8
    (61.7)
    Full 48 hour post surgery period
    125.6
    (80.7)
    145.7
    (99.2)
    3. Secondary Outcome
    Title Patient's Subjective Rating of Pain
    Description Patients are asked if their pain is acceptable (yes/no)
    Time Frame 3 days after surgery

    Outcome Measure Data

    Analysis Population Description
    Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Measure Participants 0 0
    4. Secondary Outcome
    Title UPAT Score Before and After Physical Therapy
    Description Pain in score change after physical therapy
    Time Frame 3 days after surgery

    Outcome Measure Data

    Analysis Population Description
    Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Measure Participants 0 0
    5. Secondary Outcome
    Title Ambulation During Physical Therapy
    Description The length (in feet) patient is able to ambulate during physical therapy
    Time Frame 48 hours after surgery

    Outcome Measure Data

    Analysis Population Description
    Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    Measure Participants 0 0

    Adverse Events

    Time Frame 48 hours post surgery
    Adverse Event Reporting Description
    Arm/Group Title ROP/KET/CLON/EPI/SAL Placebo
    Arm/Group Description Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
    All Cause Mortality
    ROP/KET/CLON/EPI/SAL Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/34 (0%) 0/30 (0%)
    Serious Adverse Events
    ROP/KET/CLON/EPI/SAL Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/34 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    ROP/KET/CLON/EPI/SAL Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/34 (0%) 0/30 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Teresa Potter
    Organization Virginia Commonwealth University
    Phone 804-828-6749
    Email teresa.potter@vcuhealth.org
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT02570503
    Other Study ID Numbers:
    • HM20004125
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022