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NCT Number: NCT01042093

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

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.

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Key information

Conditions

Osteoarthritis,Knee Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating women
  • Presence of allergies or contraindication to any medications indicated in the study
  • Contraindication to or failure of spinal anesthesia
  • Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
  • Patients with a diagnosis of inflammatory arthritis
  • Previous major bone surgery in the operative knee
  • Simultaneous, bilateral TKRs

Treatment and study plan

Ropivacaine

Drug

Ropivacaine 5mg/ml (49.25 ml)

Other names: periarticular injection

Toradol

Drug

Toradol 30mg/ml (1 ml)

Other names: periarticular injection

Clonidine

Drug

Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

Other names: periarticular injection

Epinephrine

Drug

Epinephrine 1 mg/ml (0.5 ml)

Other names: periarticular injection

Primary outcomes

  1. Numerical Rating Scale (NRS) Pain Scores During Hospitalization.

    Time frame: 2 days after surgery

    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 outcomes

  1. Narcotic Consumption During Hospitalization

    Time frame: 4 days

    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.

  2. Knee Society Pain Scores at 6 Week Follow-up Appointment

    Time frame: 6 weeks after surgery

    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.

Sponsors and collaborators

Lead sponsor

Towson Orthopaedic Associates

Other

Registry information

Official study title

Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 5, 2010
Registry last updated
Nov 8, 2013

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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