UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013364
Receipt number R000015591
Scientific Title A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty
Date of disclosure of the study information 2014/03/07
Last modified on 2014/05/25 12:26:41

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Basic information

Public title

A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty

Acronym

Postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty

Scientific Title

A prospective, single-center randomised double-blinded parallel-group comparison study of the postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty

Scientific Title:Acronym

Postoperative pain control efficacy of a sciatic nerve block versus combined local anaesthetic infiltration and continuous femoral nerve block after total knee arthroplasty

Region

Japan


Condition

Condition

Degenerative arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare the postoperative analgesic effect of local anaesthetic infiltration with that of sciatic nerve block in combination with a continuous femoral nerve block after total knee arthroplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of changes in Numerical Rating Scale (NRS) between local anaesthetic infiltration and sciatic nerve block at five time points; on exiting the operating room and 3, 6, 12, 24 hour later.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Subjects were administered a 20-ml bolus injection of 0.375% ropivacaine for a femoral nerve block and catheter were inserted for a continuous femoral nerve block after the insertion of a laryngeal airway in combination with a nerve stimulus. The local anaesthetic mixture (100 ml of 0.2% ropivacaine by adding 0.5 mg of adrenaline) was administered three times in divided doses during operation. A continuous femoral block of 0.2% ropivacaine 5 ml h-1 was commenced at the end of the operation.
The participants were administered a 25-mg diclofenac suppository if the NRS was >3 upon exiting the operating room and at 3, 6, 12, and 24 h after that time or at any other time they requested an analgesic with an NRS greater than 3. The participants had received an explanation that the number, 0, on a ruler represented the absence of pain and the number, 10, represented the most severe pain they had ever felt and were asked to point to the number that best estimated their pain on the scale (NRS). Repeated administrations of a 25-mg diclofenac suppository were allowed after a 3-h interval. If this method was inadequate and the patient could not cope with the pain (NRS, >3), 15 mg of pentazocine was injected intramuscularly.
Nurses in the operating room and on the ward who were blinded to the group allocations recorded the NRS.

Interventions/Control_2

Subjects were moved to a lateral recumbent position after insertion of a laryngeal airway and administered a 20-ml bolus injection of 0.375% ropivacaine for a sciatic nerve block. After a sciatic nerve block, the patients were moved into a supine position and administered a 20-ml bolus injection of 0.375% ropivacaine for a femoral nerve block and catheter was inserted for a continuous femoral nerve block. A continuous femoral nerve block of 0.2% ropivacaine 5 ml h-1 was commenced at the end of the operation.
The participants were administered a 25-mg diclofenac suppository if the NRS was >3 upon exiting the operating room and at 3, 6, 12, and 24 h after that time or at any other time they requested an analgesic with an NRS greater than 3. The participants had received an explanation that the number, 0, on a ruler represented the absence of pain and the number, 10, represented the most severe pain they had ever felt and were asked to point to the number that best estimated their pain on the scale (NRS). Repeated administrations of a 25-mg diclofenac suppository were allowed after a 3-h interval. If this method was inadequate and the patient could not cope with the pain (NRS, >3), 15 mg of pentazocine was injected intramuscularly.
Nurses in the operating room and on the ward who were blinded to the group allocations recorded the NRS.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

 TKA for degenerative arthritis
 American Society of Anesthesiologists physical status, 1–3
 Weight, 40–99 kg
 Fully understood the study contents from oral and written descriptions

Key exclusion criteria

 Bilateral TKA
 Regular narcotic users
 Allergy to any study drug
 Neuromuscular disease
 Sensory disturbances of the leg
 Severe diabetes
 Heart failure (AHA >3)
&#61548; Renal impairment with an estimated glomerular filtration rate of <60 mL min-1 1.73 m-2,
&#61548; Liver dysfunction (Child&#8211;Pugh > B)
&#61548; Impossible to assess using the numeric rating scale (NRS)

Target sample size

34


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junya Oshida

Organization

Saitama City Hospital

Division name

Department of Anesthesiology

Zip code


Address

Mimuro 2460, Saitama Midori-ku, Saitama, 336-8522 Japan

TEL

048-873-4111

Email

oswillkommen@ybb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Sato

Organization

Saitama City Hospital

Division name

Department of Intensive Care

Zip code


Address

Mimuro 2460, Saitama Midori-ku, Saitama, 336-8522 Japan

TEL

048-873-4111

Homepage URL


Email

tomoyukisatoh@seagreen.ocn.ne.jp


Sponsor or person

Institute

Saitama City Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

さいたま市立病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2013 Year 06 Month 30 Day

Date of closure to data entry

2013 Year 09 Month 30 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2014 Year 01 Month 15 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 07 Day

Last modified on

2014 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name