UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024632
Receipt number R000028337
Scientific Title Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy
Date of disclosure of the study information 2016/10/30
Last modified on 2020/02/29 11:50:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy

Acronym

Effect of additional TAP block with port site infiltration after RALP

Scientific Title

Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy

Scientific Title:Acronym

Effect of additional TAP block with port site infiltration after RALP

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate alagesic effect of additional transverse abdominis plane block (TAP block) with port site infiltration of local anesthetics in patients scheduled robot asststed laparoscopic prostatectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative pain evaluated numerical rating scale (NRS) at immediately, 1h, 4h and 24h after operation

Key secondary outcomes

Intravenous fentanyl dose during first postoperative 24h by using patient controlled method


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive 0.375%ropivacaine(15ml on each side) by TAP block before awaking from anethesia. All patients receive port site infiltration with 10ml of 0.2%ropivacaine.

Interventions/Control_2

Patients receive saline(15ml on each side) by TAP block before awaking from anethesia. All patients receive port site infiltration with 10ml of 0.2%ropivacaine.

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male

Key inclusion criteria

All ASA 1-2 patients except for exclusion criteria

Key exclusion criteria

1) ASA 3 or higher
2) Body weight less than 40kg
3) Preoperative opioid use
4) Contraindication with Desflurane
(predisposing malignant hyperthermia, existing neuromuscular disease)

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Taninishi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Anesthesiology and Resuscitology

Zip code

7008558

Address

2-5-1, Shikata-Cho, Kita-ku, Okayama, Japan

TEL

086-235-7327

Email

tanini-h@okayama-u.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Taninishi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Anesthesiology and Resuscitology

Zip code

7008558

Address

2-5-1, Shikata-Cho, Kita-ku, Okayama, Japan

TEL

086-235-7327

Homepage URL


Email

tanini-h@okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Address

2-5-1, Shikata-cho, Kita-ku, Okayama, Japan

Tel

086-235-7327

Email

tanini-h@okayama-u.ac.jp


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

岡山大学病院 (岡山県)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 30 Day


Related information

URL releasing protocol

https://www.nature.com/articles/s41598-020-60687-y

Publication of results

Published


Result

URL related to results and publications

https://www.nature.com/articles/s41598-020-60687-y

Number of participants that the trial has enrolled

108

Results

TAP block by anesthesiologists of varied level of training reduced postoperative pain immediate after RALP. TAP block had fundamental analgesic effect, but this benefit was too small to reduce postoperative 24-hour fentanyl consumption.

Results date posted

2020 Year 02 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 02 Month 28 Day

Baseline Characteristics

Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y

Participant flow

Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y

Adverse events

No adverse effects

Outcome measures

Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 28 Day

Date of IRB

2017 Year 02 Month 21 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry

2018 Year 10 Month 31 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 30 Day

Last modified on

2020 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name