UMIN-CTR Clinical Trial

Public title

A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery

Acronym

A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery

Scientific Title

A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery

Scientific Title:Acronym

A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery

Region

Japan

Condition

Patients undergoing laparoscopic surgery

Classification by specialty

Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Operative medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the usefulness of under peritoneal swelling anesthesia as postoperative analgesia with conventional management including epidural anesthesia of postoperative pain relief in laparoscopic surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Visual analogue scale of under peritoneal swelling anesthesia as postoperative analgesia conventional management including epidural anesthesia of postoperative pain relief in laparoscopic surgery.

Key secondary outcomes

Analgesic effect (VAS or PHS of up to five days after surgery)
Drug use during surgery, postoperative (type and quantity)
Complications associated with anesthesia
Anesthesia procedure time

Study type

Interventional

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Under peritoneal swelling anesthesia in the intervention group

Interventions/Control_2

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

Age of patients:20 years of age or older at the time of acquisition consent
PS = 0 or 1
patient under peritoneal swelling anesthesia is enforceable
Patients who are undergoing for laparoscopic surgery without incision other than a small incision of the umbilical region(the definition of small incision is less than 5cm, port insertion hole is assumed to be excluded)
After receiving a sufficient explanation upon participation of this study, on a full understanding, patients who obtained the document voluntary consent

Key exclusion criteria

Patients with oral analgesics on regularly
Patients with restrictions on the use of analgesics
Patients with mental illness, alcoholism
Patient for a long time surgery is predicted by adhesion, etc.
Patients who have migrated to open surgery
Patients who principal investigator was deemed inappropriate as a subject

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Hirano

Organization

Hokkaido University Graduate School of Medicene

Division name

Department of Gastroenterological Surgery II

Zip code

Address

Japan, Hokkaido, Sapporo, North15 west5

TEL

011-706-7714

Email

satto@msa.biglobe.ne.jp

Name of contact person

1st name
Middle name
Last name	Dai Miyazaki

Organization

Hokkaido University Graduate School of Medicene

Division name

Department of Gastroenterological Surgery II

Zip code

Address

Japan, Hokkaido, Sapporo, North15 west5

TEL

011-706-7714

Homepage URL

Email

dmiyazaki-hok@umin.ac.jp

Institute

Hokkaido University Graduate School of Medicene Department of Gastroenterological Surgery II

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

北海道大学病院（北海道）

Date of disclosure of the study information

2014

Year

07

Month

10

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

2014

Year

06

Month

12

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

08

Day

Last modified on

2015

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016628