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

Sponsoren

Hauptsponsor: Tan Tock Seng Hospital

Quelle Tan Tock Seng Hospital
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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

Gesamtstatus Completed
Anfangsdatum July 2009
Fertigstellungstermin December 2011
Primäres Abschlussdatum June 2011
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Incidence of patients with significant pain on movement on day 1 post surgery Post op day 1
Sekundäres Ergebnis
Messen Zeitfenster
Functional recovery During hospitalization, week 2, week 12
Einschreibung 200
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: Continuous Femoral Nerve Block

Beschreibung: 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.

Anderer Name: Bupivacaine

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 40 Years

Maximales Alter: 90 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Ort
Einrichtung: Tan Tock Seng Hospital
Standort Länder

Singapore

Überprüfungsdatum

August 2010

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Tan Tock Seng Hospital

Vollständiger Name des Ermittlers: Chan Ee Yuee

Ermittlertitel: Dr

Schlüsselwörter
Hat den Zugriff erweitert No
Anzahl der Waffen 3
Armgruppe

Etikette: Continuous Femoral Nerve Block

Art: Experimental

Etikette: Single-Inj Nerve Block with IV PCA

Art: Active Comparator

Etikette: IV PCA

Art: Active Comparator

Akronym PCA
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Single (Outcomes Assessor)

Quelle: ClinicalTrials.gov