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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Continuous Femoral Nerve Block

• Registration Number: NCT01187537
• Lead Sponsor: Tan Tock Seng Hospital

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 Timeline

• Study Start: 2009-07
• Status Verified: 2010-08
• Study First Submitted: 2010-08-22
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-Inj Nerve Block with IV PCA	Continuous Femoral Nerve Block	-
Continuous Femoral Nerve Block	Continuous Femoral Nerve Block	-
IV PCA	Continuous Femoral Nerve Block	-

Primary Outcome Measures

Name	Time	Method
Incidence of patients with significant pain on movement on day 1 post surgery	Post op day 1

Secondary Outcome Measures

Name	Time	Method
Functional recovery	During hospitalization, week 2, week 12

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore