Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

• ClinicalTrials.gov Identifier: NCT00901628
• Recruitment Status: Completed
• First Posted: May 14, 2009
• Results First Posted: January 25, 2013
• Last Update Posted: January 25, 2013
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Tae Kyun Kim, Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Drug: ropivacaine; Drug: morphine sulfate; Drug: ketorolac; Drug: epinephrine; Drug: cefuroxime	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
• Study Start Date: April 2008
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Periarticular Injection group; Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime	Drug: ropivacaine; 300mg (0.75%, 40cc) intraoperative periarticular injection; Drug: morphine sulfate; 10mg intraoperative periarticular injection; Drug: ketorolac; 30 mg intraoperative periarticular injection; Drug: epinephrine; 300 microgram (1:1000) intraoperative periarticular injection; Drug: cefuroxime; 750mg intraoperative periarticular injection
No Intervention: No Injection group; usual postoperative care without periarticular injection

Outcome Measures

Primary Outcome Measures :

1. Pain( Visual Analog Scale ) [ Time Frame: the night after surgery ]
   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.

Secondary Outcome Measures :

1. Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery [ Time Frame: 24 hours postoperative ]
   Fentanyl based PCA consumption via PCA pump (microgram)
2. Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery [ Time Frame: 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.
3. the Proportion of Patients Who Were Satisfied With the Pain Management [ Time Frame: postoperative 7 day ]
4. The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended [ Time Frame: 24 hours postoperative ]
5. Maximal Flexion Angle Degree on Postoperative 7 Day [ Time Frame: postoperative 7 day ]
   An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 81 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Tae Kyun Kim, MD, PhD; Joint Recontruction Center, Seoul National University Bundang hospital

More Information

• Responsible Party: Tae Kyun Kim, Joint reconstruction center, Dept. of orthopaedic surgery, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT00901628
• Other Study ID Numbers: B-0804/056-021
• First Posted: May 14, 2009
• Results First Posted: January 25, 2013
• Last Update Posted: January 25, 2013
• Last Verified: December 2012

Keywords provided by Tae Kyun Kim, Seoul National University Hospital:

periarticular multimodal drug injection

Additional relevant MeSH terms:

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Cefuroxime; Cefuroxime axetil; Ketorolac; Ketorolac Tromethamine; Epinephrine; Racepinephrine; Morphine; Ropivacaine; Epinephryl borate; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists