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

Osteoarthritis,Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042093
• Other study ID #: 1113723
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: September 5, 2013
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2013
• Source: Towson Orthopaedic Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Drug:
• Ropivacaine
Ropivacaine 5mg/ml (49.25 ml)
• Toradol
Toradol 30mg/ml (1 ml)
• Clonidine
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
• Epinephrine
Epinephrine 1 mg/ml (0.5 ml)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Towson Orthopaedic Associates

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) Pain Scores During Hospitalization.	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	No
Secondary	Narcotic Consumption During Hospitalization	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	No
Secondary	Knee Society Pain Scores at 6 Week Follow-up Appointment	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	No