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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2010

Last Updated Date

August 23, 2010

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01187537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Estimated Completion Date

May 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ee Yuee Chan

eeyuee@gmail.com

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT01187537

Other Study ID Numbers ^ICMJE

SIG/09052

Has Data Monitoring Committee

Yes

Responsible Party

Ee Yuee Chan, Tan Tock Seng Hospital

Study Sponsor ^ICMJE

Tan Tock Seng Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Ee Yuee Chan	Tan Tock Seng Hospital
Principal Investigator:	Nelson Chua	Tan Tock Seng Hospital

Information Provided By

Tan Tock Seng Hospital

Verification Date

August 2010

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

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