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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous Femoral Nerve Block

Group Type EXPERIMENTAL

Continuous Femoral Nerve Block

Intervention Type PROCEDURE

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.

Single-Inj Nerve Block with IV PCA

Group Type ACTIVE_COMPARATOR

Continuous Femoral Nerve Block

Intervention Type PROCEDURE

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.

IV PCA

Group Type ACTIVE_COMPARATOR

Continuous Femoral Nerve Block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Bupivacaine

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No