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

NCT01042093 | Completed Results

• 1 other identifier: 1113723
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis,Knee

Keywords

Analgesia; postoperative pain; periarticular; arthroplasty; pain management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Narcotic Consumption During Hospitalization

  4 days

• Knee Society Pain Scores at 6 Week Follow-up Appointment

  6 weeks after surgery

Study Arms (4)

ROP/EPI/TOR/CLO

ACTIVE COMPARATOR

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; Drug: Toradol; Drug: Clonidine; Drug: Epinephrine

ROP/EPI/TOR

ACTIVE COMPARATOR

Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)

Drug: Ropivacaine; Drug: Toradol; Drug: Epinephrine

ROP/EPI/CLO

ACTIVE COMPARATOR

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; Drug: Clonidine; Drug: Epinephrine

ROP/EPI

ACTIVE COMPARATOR

Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml)

Drug: Ropivacaine; Drug: Epinephrine

Interventions

Ropivacaine DRUG

Ropivacaine 5mg/ml (49.25 ml)

Also known as: periarticular injection

ROP/EPI; ROP/EPI/CLO; ROP/EPI/TOR; ROP/EPI/TOR/CLO

Toradol DRUG

Toradol 30mg/ml (1 ml)

Also known as: periarticular injection

ROP/EPI/TOR; ROP/EPI/TOR/CLO

Clonidine DRUG

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

Also known as: periarticular injection

ROP/EPI/CLO; ROP/EPI/TOR/CLO

Epinephrine DRUG

Epinephrine 1 mg/ml (0.5 ml)

Also known as: periarticular injection

ROP/EPI; ROP/EPI/CLO; ROP/EPI/TOR; ROP/EPI/TOR/CLO

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Towson Orthopaedic Associates: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia; Pain, Postoperative

Interventions

Ropivacaine; Ketorolac Tromethamine; Clonidine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: David F. Dalury, MD
• Organization: Towson Orthopaedic Associates

ddalury@gmail.com

410-337-7900

Study Officials

• David F. Dalury, MD

  Towson Orthpaedic Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 8, 2013
• Results First Posted: November 8, 2013

Record last verified: 2013-09