NCT01187537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 13, 2016

Status Verified

August 1, 2010

Enrollment Period

1.9 years

First QC Date

August 22, 2010

Last Update Submit

May 12, 2016

Conditions

Pain

Keywords

Knee ReplacementAnalgesiaAnalgesicsNerve blocksRecovery of functionsPost operative analgesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of patients with significant pain on movement on day 1 post surgery

    Post op day 1

Secondary Outcomes (1)

  • Functional recovery

    During hospitalization, week 2, week 12

Study Arms (3)

Continuous Femoral Nerve Block

EXPERIMENTAL
Procedure: Continuous Femoral Nerve Block

Single-Inj Nerve Block with IV PCA

ACTIVE COMPARATOR
Procedure: Continuous Femoral Nerve Block

IV PCA

ACTIVE COMPARATOR
Procedure: Continuous Femoral Nerve Block

Interventions

Continuous Femoral Nerve BlockPROCEDURE

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.

Also known as: Bupivacaine
Continuous Femoral Nerve BlockIV PCASingle-Inj Nerve Block with IV PCA

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 24782108DERIVED

MeSH Terms

Conditions

PainAgnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ee Yuee Chan

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

  • Nelson Chua

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 22, 2010

First Posted

August 24, 2010

Study Start

July 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

May 13, 2016

Record last verified: 2010-08

Locations

SG(1)