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

May 12, 2016 updated by: Chan Ee Yuee, Tan Tock Seng Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other Names:
  • Bupivacaine
Active Comparator: Single-Inj Nerve Block with IV PCA
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.
Other Names:
  • Bupivacaine
Active Comparator: IV PCA
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.
Other Names:
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of patients with significant pain on movement on day 1 post surgery
Time Frame: Post op day 1
Post op day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional recovery
Time Frame: During hospitalization, week 2, week 12
During hospitalization, week 2, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ee Yuee Chan, Tan Tock Seng Hospital
  • Principal Investigator: Nelson Chua, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 22, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

August 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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