Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
This study has been completed.
Sponsor:
Towson Orthopaedic Associates
Information provided by (Responsible Party):
David F. Dalury, MD, Towson Orthopaedic Associates
ClinicalTrials.gov Identifier:
NCT01042093
First received: January 4, 2010
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery. 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 200 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 |
|---|---|
|
Total Knee Replacement |
Drug: Periarticular Injection - Group A Drug: Periarticular Injection - Group B Drug: Periarticular Injection - Group C Drug: Periarticular Injection - Group D |
| 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:
MedlinePlus related topics:
Knee Replacement
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
Clonidine
Clonidine hydrochloride
U.S. FDA Resources
Further study details as provided by Towson Orthopaedic Associates:
Primary Outcome Measures:
- The primary endpoint will be the Numerical Rating Scale (NRS) pain scores 1 hour postoperatively in the post anesthesia unit, then every 8 hours on the Orthopedic unit inpatient unit. [ Time Frame: 3 days after surgery and at the 6 weeks followup appt ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- IV Morphine consumption during hospitalization [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| 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: Group A: Ropivacaine,Epinephrine,Toradol, Clonidine |
Drug: Periarticular Injection - Group A
Ropivicaine 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)
|
| Active Comparator: Group B-Ropivacaine, Epinephrine, Toradol |
Drug: Periarticular Injection - Group B
Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
|
| Active Comparator: Group C- Ropivacaine, Epinephrine,Clonidine |
Drug: Periarticular Injection - Group C
Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
|
| Active Comparator: Group D - Ropivacaine, Epinephrine |
Drug: Periarticular Injection - Group D
Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
|
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations 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 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Towson Orthopaedic Associates:
|
Analgesia postoperative pain periarticular arthroplasty To compare the 4 groups of periarticular injection combinations used for pain management following total knee replacement |
Additional relevant MeSH terms:
|
Epinephrine Clonidine Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents |
Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Antihypertensive Agents Sympatholytics Adrenergic alpha-2 Receptor Agonists Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013