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Clinical Trials/NCT01187537
NCT01187537
Completed
Not Applicable

Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement

Tan Tock Seng Hospital1 site in 1 country200 target enrollmentJuly 2009
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Tan Tock Seng Hospital
Enrollment
200
Locations
1
Primary Endpoint
Incidence of patients with significant pain on movement on day 1 post surgery
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.

Detailed Description

Primary Outcome Measures: * Incidence of patients with significant pain on movement on day 1 post surgery * Range of knee flexion Secondary Outcome Measures: * Pain intensity (rest/movement) * Functional recovery * Knee Injury and Osteoarthritis Score * Side effects/ Adverse outcomes * SF12 Quality of Life Questionnaire * Length of stay

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
December 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tan Tock Seng Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chan Ee Yuee

Dr

Tan Tock Seng Hospital

Eligibility Criteria

Inclusion Criteria

  • 40 years and above
  • Osteoarthritis
  • Primary unilateral total knee replacement
  • No other lower extremity joint disease
  • ASA I-III
  • Body mass index \< 35
  • No severe cardiac or pulmonary diseases
  • No chronic narcotic therapy or illicit drug use
  • Mentally competent to understand study procedures and use of pain scales
  • Able to provide informed consent

Exclusion Criteria

  • Any cause for knee replacement other than osteoarthritis
  • Total knee revision
  • Any contraindication for femoral block
  • Abnormal coagulation studies
  • Thrombocytopenia less than 100,000/cc
  • Known hepatic or renal insufficiency
  • Neurological disease involving lower extremities
  • Major surgery during the last 2 weeks pre-operatively
  • History of allergy to study medications
  • History of post-operative bleeding over 2000 cc/24 hours

Outcomes

Primary Outcomes

Incidence of patients with significant pain on movement on day 1 post surgery

Time Frame: Post op day 1

Secondary Outcomes

  • Functional recovery(During hospitalization, week 2, week 12)

Study Sites (1)

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