Clinical trial NCT01187537: Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Knee Replacement
Analgesia
Analgesics
Nerve blocks
Recovery of functions
Post operative analgesia
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Incidence of patients with significant pain on movement on day 1 post surgery
timeFrame: Post op day 1
Secondary outcomes:
measure: Functional recovery
timeFrame: During hospitalization, week 2, week 12
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Ee Yuee Chan
role: PRINCIPAL_INVESTIGATOR
affiliation: Tan Tock Seng Hospital
name: Nelson Chua
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan EY, Teo YH, Assam PN, Fransen M. Functional discharge readiness and mobility following total knee arthroplasty for osteoarthritis: a comparison of analgesic techniques. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1688-94. doi: 10.1002/acr.22361.