UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024815
Receipt number R000028528
Scientific Title Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Date of disclosure of the study information 2016/12/01
Last modified on 2021/11/16 13:50:28

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Basic information

Public title

Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy

Acronym

Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy

Scientific Title

Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy

Scientific Title:Acronym

Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy

Region

Japan


Condition

Condition

gallbladder disease

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this research is making it clear which anesthesia of a rectus sheath block procedure and the local infiltration anesthesia is superior for postoperative pain after laparoscopic cholecystectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain evaluation with VAS at the first day after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

rectus sheath block group

Interventions/Control_2

local infiltration anesthesia group

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who have an electively operation of laparoscopic cholecystectomy for the benign gallbladder disease and who agree to this study

Key exclusion criteria

none

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Naomi
Middle name
Last name Kitamura

Organization

Shiga University of Medical Science

Division name

department of surgery

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN

TEL

077-548-2238

Email

naomik@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Naomi
Middle name
Last name Kitamura

Organization

Shiga University of Medical Science

Division name

department of surgery

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN

TEL

077-548-2238

Homepage URL


Email

naomik@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

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

SUMS Research Ethics Committee

Address

Seta Tsukinowa cho, Otsu city, Shiga Pref.

Tel

077-548-3576

Email

hqrec@belle.shiga-med.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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1111/ases.12957

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1111/ases.12957

Number of participants that the trial has enrolled

62

Results

This study enrolled 62 patients (RSB group=31, LA group=31). On POD1, the mean VAS scores were 36.41+-8.9 and 29.4+-15.4 in the RSB group and LA groups, respectively, showing that the LA group tended to describe lesser postoperative pain than the RSB group (P=0.062).
VAS scores on POD1 were not different between the groups. LC patients might obtain postoperative pain control via long-acting local analgesia.

Results date posted

2021 Year 11 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 06 Month 22 Day

Baseline Characteristics

Patients aged > 20 years and scheduled to undergo elective LC for benign gallbladder disease at our hospital were approached for inclusion in the study. Patients were excluded if any the following was applicable: patient refusal, hypersensitivity to local anesthetics, inability to understand the visual analogue scale (VAS) scores for pain due to any reason.

Participant flow

After obtaining informed consent from patients, they were enrolled and assigned to either the RSB group or LA group (1:1, block size 4) using APS-Cloud system. The allocation was done by the minimization method that assumed age and sex as assignment factors. This system was able to randomly separate patients to two groups so that there were no deflections of age and sex. Although the surgeons were not blinded to the treatment group, all the patients were blinded to their group allocation. There were no protocol violations.

Adverse events

No adverse events associated with the nerve block procedure such as neuropathy or LA were reported in any patient.

Outcome measures

The primary endpoint of this study was to compare VAS scores of the RSB group with those with the LA group on POD1. Secondary endpoints were VAS scores on POD0, POD2 and POD3, and face scale score, areas under the curve of VAS score, frequency of using analgesic agents, and area of pain on POD0 to POD3.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 11 Month 07 Day

Date of IRB

2016 Year 11 Month 07 Day

Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry

2021 Year 06 Month 22 Day

Date trial data considered complete

2021 Year 06 Month 22 Day

Date analysis concluded

2021 Year 06 Month 22 Day


Other

Other related information



Management information

Registered date

2016 Year 11 Month 12 Day

Last modified on

2021 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name