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

Pain Clinical Trial

— PCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187537
• Other study ID #: SIG/09052
• Status: Completed
• Phase: N/A
• First received: August 22, 2010
• Last updated: May 12, 2016
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2010
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: NHG Domain Specific Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of patients with significant pain on movement on day 1 post surgery		Post op day 1	No
Secondary	Functional recovery		During hospitalization, week 2, week 12	No