UMIN-CTR Clinical Trial

Public title

Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.

Acronym

Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.

Scientific Title

Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.

Scientific Title:Acronym

Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.

Region

Japan

Condition

Patients who are scheduled for gynecological lower abdominal surgery.

Classification by specialty

Obstetrics and Gynecology

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will compared low concentration-high volume ropivacaine with high concentration-low volume ropivacaine using for transversus abdominis plane block.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postoperative morphine consumption after 4, 24, 48, and 72 hours.Using patient controlled analgesia.

Key secondary outcomes

Pain:Visual analogue scale(VAS) at rest and at cough after 4, 24, 48, and 72 hours postoperation.
Adverse event.
Blood pressure and SpOs after 4,24,48 and 72 hours postoperation,
Ropivacaine plasma concentration after 0,15,30,45,60 and 120 mins after transversus abdominis plane block.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

Patinets will receive ultrasound-guided transversus abdominis plane block using 0.4%,3 mg/kg of ropivacaine.

Interventions/Control_2

Patinets will receive ultrasound-guided transversus abdominis plane block using 0.2%,3 mg/kg of 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

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1)Patients who are scheduled for gynecological lower abdominal surgery in Nagoya university hospital.
2)American Society of Anethesiologists physical status in 1, 2 or 3.
3)Patients who can evaluate the pain using visual analogue scale(VAS)
4)Patients who can give written informed consent,

Key exclusion criteria

1)Patients who have stomach ulcer, renal failure or liver failure.
2)Patients who have allergy to the drugs which will going to use in this trial.
3)Patients who have severe obesity over BMI 30.
4)Patients who have contraindication of Ropivacaine.
5)Patients who are regarded ineligible by doctors with ather reasons.

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Kimitoshi Nishiwaki

Organization

Nagoya University Hospital

Division name

Department of Anesthesiology

Zip code

Address

65, Thurumai town, Showa ward, Nagoya-city, Aichi

TEL

052-744-2340

Email

a-ohashi@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akiko Akane

Organization

Nagoya University Hospital

Division name

Department of Anethesiology

Zip code

Address

65, Thurumai town, Showa ward, Nagoya city, Aichi

TEL

052-744-2340

Homepage URL

Email

a-ohashi@med.nagoya-u.ac.jp

Institute

Nagoya University 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

名古屋大学医学部付属病院（愛知県）

Date of disclosure of the study information

2015

Year

11

Month

12

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

03

Month

14

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

29

Day

Last follow-up date

2015

Year

09

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

12

Day

Last modified on

2015

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022828