UMIN-CTR Clinical Trial

Public title

Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty

Acronym

Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty

Scientific Title

Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty

Scientific Title:Acronym

Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty

Region

Japan

Condition

Patients undergoing 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 this study is to evaluate the analgesic efficacy of continuous sciatic nerve block compared with single shot sciatic nerve block after total knee arthroplasty. In addition to either continuous or single shot sciatic nerve block, both groups are provided with continuous femoral nerve block and intravenous morphine patient-controlled analgesia system concurrently.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Total morphine consumption within 48 hours after surgery

Key secondary outcomes

Visual analogue scale scores, incidence of adverse effects of morphine, the maximum angle of the continuous passive motion of the operated knee on the postoperative day 7 and hospital length of stay

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

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

Medicine

Maneuver

Interventions/Control_1

Femoral and sciatic nerve blocks are performed just before surgery and perineural catheters are inserted for both peripheral nerves. After surgery, continuous sciatic nerve block (5 ml/h of 0.2% ropivacaine) is provided for 48 hours in addition to continuous femoral nerve block and intravenous morphine patient-controlled analgesia system (1 mg morphine every 10 minutes as needed).

Interventions/Control_2

Femoral and sciatic nerve blocks are performed just before surgery and perineural catheters are inserted for both peripheral nerves. After surgery, sham continuous sciatic nerve block (5 ml/h of normal saline) is provided for 48 hours in addition to continuous femoral nerve block and intravenous morphine patient-controlled analgesia system (1 mg morphine every 10 minutes as needed).

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

18

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

All patients undergoing unilateral total knee arthroplasty

Key exclusion criteria

ASA physical status above 3
Fixed valgus and flexion deformities
Rivision knee replacement
Impaired cognitive function
Neuromuscular diseases
Vascular diseases on lower extremities
Diabetes mellitus with insulin therapy
Morbid obesity (body mass index > 35)
Impaired renal function (serum creatinine > 1.5)
Contraindication for peripheral nerve blocks (coagulation abnormalities, infection at the puncture site, allegy to local anesthetics)
Gastric ulcer
Allergy to NSAIDs
Pregnancy or breast feeding

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Keita Sato

Organization

Kitano Hospital

Division name

Department of anesthesiology

Zip code

Address

2-4-20, Ogi-machi, Kita-ku, Osaka, Japan

TEL

06-6312-1221

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kitano Hospital

Division name

Department of anesthesiology

Zip code

Address

2-4-20,Ogi-machi, Kita-ku, Osaka, Japan

TEL

Homepage URL

Email

Institute

Kitano Hospital

Institute

Department

Personal name

Organization

None

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

財団法人田附興風会医学研究所　北野病院

Date of disclosure of the study information

2011

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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

2011

Year

05

Month

08

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2013

Year

03

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

06

Month

16

Day

Last modified on

2013

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006847