Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Tan Tock Seng Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01187537
First received: August 22, 2010
Last updated: August 23, 2010
Last verified: August 2010

August 22, 2010
August 23, 2010
July 2009
February 2011   (final data collection date for primary outcome measure)
Incidence of patients with significant pain on movement on day 1 post surgery [ Time Frame: Post op day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01187537 on ClinicalTrials.gov Archive Site
Functional recovery [ Time Frame: During hospitalization, week 2, week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement
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

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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pain
Procedure: Continuous Femoral Nerve Block
20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
Other Name: Bupivacaine
  • Experimental: Continuous Femoral Nerve Block
    Intervention: Procedure: Continuous Femoral Nerve Block
  • Active Comparator: Single-Inj Nerve Block with IV PCA
    Intervention: Procedure: Continuous Femoral Nerve Block
  • Active Comparator: IV PCA
    Intervention: Procedure: Continuous Femoral Nerve Block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
May 2011
February 2011   (final data collection date for primary outcome measure)

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
  • History of opioid or alcohol abuse
  • Currently taking or has taken opioid > 30 consecutive days of daily use at a daily dose > 15mg morphine, within the past 2 weeks prior to surgery
  • Previously has not responded to opioid analgesics for treatment of pain
  • Pregnancy or breastfeeding
Both
40 Years to 90 Years
No
Contact: Ee Yuee Chan eeyuee@gmail.com
Singapore
 
NCT01187537
SIG/09052
Yes
Ee Yuee Chan, Tan Tock Seng Hospital
Tan Tock Seng Hospital
Not Provided
Principal Investigator: Ee Yuee Chan Tan Tock Seng Hospital
Principal Investigator: Nelson Chua Tan Tock Seng Hospital
Tan Tock Seng Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP