Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

NCT ID: NCT00901628

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-04-30

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.

Detailed Description

The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Periarticular Injection group

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

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

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

morphine sulfate

Intervention Type: DRUG

10mg intraoperative periarticular injection

ketorolac

Intervention Type: DRUG

30 mg intraoperative periarticular injection

epinephrine

Intervention Type: DRUG

300 microgram (1:1000) intraoperative periarticular injection

cefuroxime

Intervention Type: DRUG

750mg intraoperative periarticular injection

No Injection group

usual postoperative care without periarticular injection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ropivacaine

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

Intervention Type: DRUG

morphine sulfate

10mg intraoperative periarticular injection

Intervention Type: DRUG

ketorolac

30 mg intraoperative periarticular injection

Intervention Type: DRUG

epinephrine

300 microgram (1:1000) intraoperative periarticular injection

Intervention Type: DRUG

cefuroxime

750mg intraoperative periarticular injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae Kyun Kim

Joint reconstruction center, Dept. of orthopaedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Kyun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Joint Recontruction Center, Seoul National University Bundang hospital

Locations

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-0804/056-021

Identifier Type: -

Identifier Source: org_study_id