UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000053274
Receipt number	R000060802
Scientific Title	The efficacy of modified Thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and External Oblique Intercostal block (EOIB) in laparoscopic cholecystectomy: single-blind randomized controlled trial
Date of disclosure of the study information	2024/01/15
Last modified on	2024/01/05 16:18:10

* 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

The efficacy of modified Thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and External Oblique Intercostal block (EOIB) in laparoscopic cholecystectomy: single-blind randomized controlled trial

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

laparoscopic cholecystectomy

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The purpose of this study is to prospectively compare and evaluate whether M-TAPA and EOIB can be substituted for transversus abdominis plane (TAP) block as a perioperative analgesic technique for laparoscopic cholecystectomy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The primary outcome of the study was to evaluate the numerical rating scale (NRS) score at rest and during movement in the first postoperative 0, 1, 6, 12, and 24 hours in patients with TAPB, M-TAPA, or EOIB.

Key secondary outcomes

Secondary endpoints were postoperative narcotic consumption, evaluating the postoperative patient-completed QoR-15 questionnaire, the incidence of nausea and vomiting(PONV), and incidence of complications during nerve block techniques.

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

TAP block was administered bilaterally after the induction of anesthesia before the surgical procedures.

Interventions/Control_2

M-TAPA was administered bilaterally after the induction of anesthesia before the surgical procedures.

Interventions/Control_3

EOIB was administered bilaterally after the induction of anesthesia before the surgical procedures.

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

This prospective, single-blind, randomized controlled study was conducted from December 2022 to September 2023 at single center. After providing written informed consent, patients with American Society Anesthesiologists (ASA) physical status clasification scores of I or II were included in this study.

Key exclusion criteria

The exclusion criteria were known allergy to local anesthetics, body mass index(BMI) >35 kg/m2 or <17 kg/m2, advanced liver or kidney failure,history of trauma, stroke or cognitive impairment, and chronic analgesic drugs use.

Target sample size

Research contact person

Name of lead principal investigator

1st name Hideki

Middle name

Last name Matsuura

Organization

Nara medical university

Division name

Department of anesthesiology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

+81-744-29-8902

Email

hmatsura0610@naramed-u.ac.jp

Public contact

Name of contact person

1st name Hideki

Middle name

Last name Matsuura

Organization

Nara medical university

Division name

Department of anesthesiology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara 634-8522, Japan

TEL

+81-744-29-8902

Homepage URL

Email

hmatsura0610@naramed-u.ac.jp

Sponsor or person

Institute

Nara medical university

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Otemae Hospital

Address

1-5-34 Otemae Chuo-ku, Osaka, 540-0008, Japan

Tel

+81-6-6941-0484

Email

hmatsura0610@naramed-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2024 Year 01 Month 15 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

2022 Year 11 Month 16 Day

Date of IRB

2022 Year 11 Month 16 Day

Anticipated trial start date

2022 Year 12 Month 14 Day

Last follow-up date

2023 Year 09 Month 30 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2024 Year 01 Month 05 Day

Last modified on

2024 Year 01 Month 05 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060802