Skip to main content
OpenTrials
Completed

NCT Number: NCT00901628

Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joint Reconstruction Center, Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Morphine sulfate

Drug

10mg intraoperative periarticular injection

Ketorolac

Drug

30 mg intraoperative periarticular injection

Epinephrine

Drug

300 microgram (1:1000) intraoperative periarticular injection

cefuroxime

Drug

750mg intraoperative periarticular injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 14, 2009
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.