Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901628
• Other study ID #: B-0804/056-021
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: December 15, 2012
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• ropivacaine
300mg (0.75%, 40cc) intraoperative periarticular injection
• morphine sulfate
10mg intraoperative periarticular injection
• ketorolac
30 mg intraoperative periarticular injection
• epinephrine
300 microgram (1:1000) intraoperative periarticular injection
• cefuroxime
750mg intraoperative periarticular injection

Locations

Country	Name	City	State
Korea, Republic of	Joint Reconstruction Center, Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery	Fentanyl based PCA consumption via PCA pump (microgram)	24 hours postoperative	No
Secondary	Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery	An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.	24 hours after surgery	Yes
Secondary	the Proportion of Patients Who Were Satisfied With the Pain Management		postoperative 7 day	No
Secondary	The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended		24 hours postoperative	No
Secondary	Maximal Flexion Angle Degree on Postoperative 7 Day	An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day	postoperative 7 day	No