Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David F. Dalury, MD, Towson Orthopaedic Associates
ClinicalTrials.gov Identifier:
NCT01042093
First received: January 4, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.

The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.

Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.


Condition Intervention
Osteoarthritis,Knee
Drug: Ropivacaine
Drug: Toradol
Drug: Clonidine
Drug: Epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study

Resource links provided by NLM:


Further study details as provided by Towson Orthopaedic Associates:

Primary Outcome Measures:
  • Numerical Rating Scale (NRS) Pain Scores During Hospitalization. [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
    Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.


Secondary Outcome Measures:
  • Narcotic Consumption During Hospitalization [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.

  • Knee Society Pain Scores at 6 Week Follow-up Appointment [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.


Enrollment: 160
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ROP/EPI/TOR/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Drug: Ropivacaine
Ropivacaine 5mg/ml (49.25 ml)
Other Name: periarticular injection
Drug: Toradol
Toradol 30mg/ml (1 ml)
Other Name: periarticular injection
Drug: Clonidine
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Other Name: periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Name: periarticular injection
Active Comparator: ROP/EPI/TOR
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
Drug: Ropivacaine
Ropivacaine 5mg/ml (49.25 ml)
Other Name: periarticular injection
Drug: Toradol
Toradol 30mg/ml (1 ml)
Other Name: periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Name: periarticular injection
Active Comparator: ROP/EPI/CLO
Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Drug: Ropivacaine
Ropivacaine 5mg/ml (49.25 ml)
Other Name: periarticular injection
Drug: Clonidine
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Other Name: periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Name: periarticular injection
Active Comparator: ROP/EPI
Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml)
Drug: Ropivacaine
Ropivacaine 5mg/ml (49.25 ml)
Other Name: periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Name: periarticular injection

Detailed Description:

Data Collection:

Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.

Variables

Pre-operative Collection:

  • Vital signs
  • Hb/Hct
  • Age
  • Sex
  • BMI
  • WOMAC Score - Screen Failure at 36 or 12
  • Visual Analog Scale (VAS)

Intra-operative Collection:

  • Duration of surgery
  • Tourniquet time
  • Time of periarticular injection

Post-operative Collection:

  • Pain Scores in the inpatient post-anesthesia care unit (PACU) using the 1- to 10- point Visual Analog Scale (VAS) an admission to unit, 1 hour, 2 hour, and on discharge.
  • VAS pain scores every 8 hours on the Orthopaedic floor
  • Use of supplementary narcotics
  • Use of anti-emetics
  • Serious Adverse Events (SAE) including deep vein thrombosis (DVT) formation, pulmonary embolism (PE), myocardial infarct or other serious cardiac event, excessive bleeding
  • Length of hospital stay
  • Requirement for inpatient rehabilitation versus discharge home
  • Hours/Days to straight leg raise -POD 1, 2, 3 by MD on rounds.
  • Days to independent ambulation
  • Hemoglobin and Hematocrit levels on post-operative days one and two
  • Presence/Absence of Bowel/Bladder Function

Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain with Ambulation

  • Use of Assisted Devices
  • Distance walked
  • Range of Motion(ROM) (using Goniometer)- active and passive.

Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative days 1, 2, and 3) 6 Week visit in Office

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and Women aged 30 to 85 years
  2. Voluntary, written informed consent given to participate in this clinical investigation

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Presence of allergies or contraindication to any medications indicated in the study
  3. Contraindication to or failure of spinal anesthesia
  4. Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
  5. Patients with a diagnosis of inflammatory arthritis
  6. Previous major bone surgery in the operative knee
  7. Simultaneous, bilateral TKRs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042093

Sponsors and Collaborators
Towson Orthopaedic Associates
Investigators
Principal Investigator: David F. Dalury, MD Towson Orthpaedic Associates
  More Information

No publications provided

Responsible Party: David F. Dalury, MD, Orthopaedic Surgeon, Towson Orthopaedic Associates
ClinicalTrials.gov Identifier: NCT01042093     History of Changes
Other Study ID Numbers: 1113723
Study First Received: January 4, 2010
Results First Received: June 20, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Towson Orthopaedic Associates:
Analgesia
postoperative pain
periarticular
arthroplasty
pain management

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epinephrine
Racepinephrine
Clonidine
Epinephryl borate
Ropivacaine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on September 22, 2014