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

September 5, 2013 updated by: David F. Dalury, MD, Towson Orthopaedic Associates

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • periarticular injection
Drug: Toradol
Toradol 30mg/ml (1 ml)
Other Names:
  • periarticular injection
Drug: Clonidine
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Other Names:
  • periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Names:
  • 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 Names:
  • periarticular injection
Drug: Toradol
Toradol 30mg/ml (1 ml)
Other Names:
  • periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Names:
  • 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 Names:
  • periarticular injection
Drug: Clonidine
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
Other Names:
  • periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Names:
  • 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 Names:
  • periarticular injection
Drug: Epinephrine
Epinephrine 1 mg/ml (0.5 ml)
Other Names:
  • periarticular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 days
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.
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Towson Orthopaedic Associates

Investigators

  • Principal Investigator: David F. Dalury, MD, Towson Orthpaedic Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1113723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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