UMIN-CTR Clinical Trial

Public title

Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty

Acronym

Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty

Scientific Title

Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty

Scientific Title:Acronym

Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty

Region

Japan

Condition

patients scheduled for elective unilateral total knee arthroplasty under general anesthesia

Classification by specialty

Orthopedics	Anesthesiology	Operative medicine
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of the present study is to compare peripheral nerve block with epidural analgesia in terms of analgesic efficacy, reduction of side effect from pain management method, and early knee rehabilitation after unilateral total knee arthroplasty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Day of knee flexion achievement above 120 degrees

Key secondary outcomes

Efficacy of postoperative pain management(VAS evaluation),
Thigh and calf circumrefence,
Rate of side effect
Rehabilitation milestone(Ambulation with a cane, range of motion of operative knee)
Frequency of Additional analgesia

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

<Group CFNB(continuous femoral nerve block)>
Preoperative insertion of continuous femoral nerve block catheter and injection of 0.3% ropivacaine 60mg for continuous femoral nerve block and single-shot sciatic nerve block at the operative side (30mg ropivacaine respectively).
Postoperative continuous infusion of 0.15% ropivacaine 4mL/h for 60 hours.

Interventions/Control_2

<Group CEI(continuous epidural infusion)>
Preoperative insertion of epidural catheter at L3/4. Injection of 0.3% ropivacaine 90mg during surgery.
Postoperative continuous infusion of 0.15% ropivacaine 4mL/h for 60 hours.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled unilateral total knee arthroplasty at Osaka University Medical Hospital.

Key exclusion criteria

Inability to communicate lucidly.
Revision knee arthroplasty.
Chronic pain syndrome unrelated to knee pathology.
Allergy to local anesthetics.
ASA phisical status above III.
Chronic opioid use.
Severe diabetes mellitus with sensory disorder.
Neurologically-disabled.
Contraindications to epidural analgesia or peripheral nerve block.

Target sample size

66

Name of lead principal investigator

1st name
Middle name
Last name	Takaya Inoue

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

Address

2-2 Yamadaoka, Suita City, Osaka, Japan

TEL

06-6879-3133

Email

sakayline@gmail.com

Name of contact person

1st name
Middle name
Last name	Norihiro Sakai

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

Address

2-2 Yamadaoka, Suita City, Osaka, Japan

TEL

06-6879-3133

Homepage URL

Email

sakayline@gmail.com

Institute

Department of Anesthesia and Intensive Care Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院

Date of disclosure of the study information

2010

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23434107

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

07

Month

01

Day

Last follow-up date

2011

Year

07

Month

01

Day

Date of closure to data entry

2011

Year

07

Month

01

Day

Date trial data considered complete

2011

Year

08

Month

01

Day

Date analysis concluded

2011

Year

10

Month

01

Day

Other related information

Registered date

2010

Year

07

Month

13

Day

Last modified on

2018

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004415