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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chan Ee Yuee, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01187537
First received: August 22, 2010
Last updated: May 12, 2016
Last verified: August 2010
  Purpose
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.

Condition Intervention
Pain
Procedure: Continuous Femoral Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tan Tock Seng Hospital:

Primary Outcome Measures:
  • Incidence of patients with significant pain on movement on day 1 post surgery [ Time Frame: Post op day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional recovery [ Time Frame: During hospitalization, week 2, week 12 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Femoral Nerve Block 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
Active Comparator: Single-Inj Nerve Block with IV PCA 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
Active Comparator: IV PCA 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

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
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187537

Locations
Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Sponsors and Collaborators
Tan Tock Seng Hospital
Investigators
Principal Investigator: Ee Yuee Chan Tan Tock Seng Hospital
Principal Investigator: Nelson Chua Tan Tock Seng Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chan Ee Yuee, Dr, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01187537     History of Changes
Other Study ID Numbers: SIG/09052 
Study First Received: August 22, 2010
Last Updated: May 12, 2016
Health Authority: Singapore: Health Sciences Authority
Singapore: NHG Domain Specific Review Board

Keywords provided by Tan Tock Seng Hospital:
Knee Replacement
Analgesia
Analgesics
Nerve blocks
Recovery of functions
Post operative analgesia

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 09, 2016