Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

NCT00901628 | Completed Phase 4 Results

• 1 other identifier: B-0804/056-021
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

Conditions

Osteoarthritis, Knee

Keywords

periarticular multimodal drug injection

Outcome Measures

Primary Outcomes (1)

• Pain( Visual Analog Scale )

  An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.

  the night after surgery

Secondary Outcomes (5)

• Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery

  24 hours postoperative

• Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery

  24 hours after surgery

• the Proportion of Patients Who Were Satisfied With the Pain Management

  postoperative 7 day

• The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended

  24 hours postoperative

• Maximal Flexion Angle Degree on Postoperative 7 Day

  postoperative 7 day

Study Arms (2)

Periarticular Injection group

EXPERIMENTAL

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

Drug: ropivacaine; Drug: morphine sulfate; Drug: ketorolac; Drug: epinephrine; Drug: cefuroxime

No Injection group

NO INTERVENTION

usual postoperative care without periarticular injection

Interventions

ropivacaine DRUG

300mg (0.75%, 40cc) intraoperative periarticular injection

Periarticular Injection group

morphine sulfate DRUG

10mg intraoperative periarticular injection

Periarticular Injection group

ketorolac DRUG

30 mg intraoperative periarticular injection

Periarticular Injection group

epinephrine DRUG

300 microgram (1:1000) intraoperative periarticular injection

Periarticular Injection group

cefuroxime DRUG

750mg intraoperative periarticular injection

Periarticular Injection group

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary osteoarthritis
• Scheduled for elective total knee arthroplasty
• Signed written informed consent
• Spinal anesthesia

You may not qualify if:

• Patients refusing consents
• inability to use the outcome assessment tools
• Contraindications to regional anesthesia
• severe cardiovascular disease
• allergy or contraindication to drugs used in this study
• pre-existing neurologic disease including psychiatric disorder
• drug abuser

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine; Morphine; Ketorolac; Epinephrine; Cefuroxime

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds

Results Point of Contact

• Title: Tae Kyun Kim
• Organization: Joint Reconstruction Center, Seoul National University Bundang Hospital

osktk@snubh.org

82-31-787-7196

Study Officials

• Tae Kyun Kim, MD, PhD

  Joint Recontruction Center, Seoul National University Bundang hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joint reconstruction center, Dept. of orthopaedic surgery

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 25, 2013
• Results First Posted: January 25, 2013

Record last verified: 2012-12

Locations

KR (1)