UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041137
Receipt number R000046907
Scientific Title Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in radical hysterectomy : a pilot study
Date of disclosure of the study information 2020/07/17
Last modified on 2022/04/27 23:51:25

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Basic information

Public title

Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in radical hysterectomy : a pilot study

Acronym

Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in radical hysterectomy : a pilot study

Scientific Title

Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in radical hysterectomy : a pilot study

Scientific Title:Acronym

M-TAPA in radical hysterectomy

Region

Japan


Condition

Condition

Gynecologic malignancies for which radical hysterectomy is indicated

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Epidural anesthesia (analgesia) has been the main means of analgesia for a wide range of surgical wounds in abdominal surgery. However, removal of epidural catheter may occur epidural hematoma because anticoagulation therapy is performed in early stage at post operative period. Hence, the need for epidural anesthesia (analgesia) is swaying due to the risk and the rise of ultrasound-guided nerve block.
Tulgar et al. reported the efficacy of modified thoracoabdominal nerves block perichondrial approach (M-TAPA). M-TAPA may provide analgesia for somatic pain in Th7-Th11.
However, the efficacy of M-TAPA is reported in case reports, especially in laparoscopic surgery.
This is the prospective observational study (a pilot study) to evaluate the efficacy of M-TAPA in open abdominal surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Evaluation of anesthetized dermatomal range by M-TAPA at 2 and 24 hours after surgery

Key secondary outcomes

Numerical rating scale (NRS) at 2/24/48 hours after surgery
Opioid consumption after surgery
Frequency of non-opioid analgesic use
Occurrence of postoperative nausea and vomiting


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Female

Key inclusion criteria

Scheduled radical hysterectomy undergoing M-TAPA in addition to general anesthesia at Nara Medical University Hospital.

Key exclusion criteria

Rejection
Communication difficulty
Chronic opioid use (Daily use or usage morphine equivalent more than 60mg per day within 1 month before surgery)
Skin disease at puncture site
History of previous surgery at abdomen
Allergy to local anesthetics
Coagulation disorder
Patients who have received antithrombotic therapy and conflict with a sufficient period of drug withdrawal according to the guideline published by JSA/JSRA/JSPC
Body weight < 45 kg
BMI > 35
Visit restrictions due to prevention for COVID-19
Judged inappropriate by the investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Nobuhiro
Middle name
Last name Tanaka

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

634-8521

Address

840 Shijyo-cho, Kashihara, Nara

TEL

0744-22-3051

Email

nobuhirotanaka@naramed-u.ac.jp


Public contact

Name of contact person

1st name Nobuhiro
Middle name
Last name Tanaka

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

634-8521

Address

840 Shijyo-cho, Kashihara, Nara

TEL

0744-22-3051

Homepage URL


Email

nobuhirotanaka@naramed-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Nara Medical University Hospital Institutional Review Board.

Address

840 Shijyo-cho, Kashihara, Nara

Tel

0744-22-3051

Email

ino_rinri@naramed-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



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01652-2

Number of participants that the trial has enrolled

10

Results

The median numbers (interquartile range) of anesthetized dermatomes at 2 and 24 h postoperatively were 6 (5-7) and 6.5 (5-7) in the anterior cutaneous branch area and 5 (4-7) and 7 (5-7) in the lateral cutaneous branch area, respectively. There was an 85% chance of simultaneously acquiring analgesia in areas innervated by Th8-11, including complete block in areas innervated by the anterior cutaneous branches of Th9-10.

Results date posted

2022 Year 04 Month 27 Day

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

Main results already published

Date of protocol fixation

2020 Year 06 Month 09 Day

Date of IRB

2020 Year 07 Month 10 Day

Anticipated trial start date

2020 Year 07 Month 14 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational Study


Management information

Registered date

2020 Year 07 Month 17 Day

Last modified on

2022 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name