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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040296
Receipt No. R000045968
Scientific Title Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the patients undergoing gynecologic laparoscopic surgery: A prospective observational study.
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/09

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Basic information
Public title Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the patients undergoing gynecologic laparoscopic surgery: A prospective observational study.
Acronym Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the patients undergoing gynecologic laparoscopic surgery: A prospective observational study.
Scientific Title Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the patients undergoing gynecologic laparoscopic surgery: A prospective observational study.
Scientific Title:Acronym Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the patients undergoing gynecologic laparoscopic surgery: A prospective observational study.
Region
Japan

Condition
Condition Gynecologic laparoscopic cases which were performed under general anesthesia in conjunction with Modified-TAPA
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Transversus abdominis plane block (TAPB), which was first introduced by Rafi in 2001, has been widely performed to obtain analgesia for abdominal surgery. Although there are various approaches in TAPB, they are often insufficient for upper and lateral abdominal area. In 2019, Tulgar introduced novel approach for blocking anterior rami of spinal nerves: Modified thoracoabdominal nervers block through perichondrial approach (Modified-TAPA). It is reported that Modified-TAPA can cover upper and lateral abdominal area by single puncturing. This point needs to be clarified by assessing appropriate number of the blocked cases.
This is the prospective observational study to evaluate the anesthetized area obtained by Modified-TAPA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anesthetized thoracoabdominal areas at 2 hours after surgery (The area innervated by anterior branch and lateral cutaneous branch are evaluated separately)
Key secondary outcomes Pain scores (NRS) induced by tapping surgical site at 2 hours after surgery
Additional analgesic requirements within 24 hours after surgery
Adverse events associated with Modified-TAPA

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
70 years-old >=
Gender Female
Key inclusion criteria 1. Gynecologic laparoscopic surgery cases undergoing modified-TAPA in addition to general anesthesia at Hokkaido university hospital.
2. Scheduled surgical time <= 3 hours.
3. ASA-PS 1 or 2
Key exclusion criteria 1. Pregnancy
2. Allergy to local anesthetics
3. Communication difficulty
4. Existing neuropathy
5. Body weight <= 45 kg
6. BMI > 35
7. Past history of thoracic or abdominal surgery
8. Insufficient recovery of consciousness at 2 hours after surgery
9. Unexpected prolongation of surgical time ( > 5 hours)
10. Other patients who are judged inappropriate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Katsuhiro
Middle name
Last name Aikawa
Organization Hokkaido university hospital
Division name Anesthesiology
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo
TEL 011-716-1161
Email katsuhiro.aikawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Katsuhiro
Middle name
Last name Aikawa
Organization Hokkaido university hospital
Division name Anesthesiology
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email katsuhiro.aikawa@med.hokudai.ac.jp

Sponsor
Institute Hokkaido university hospital, department of anesthesiology
Institute
Department

Funding Source
Organization Hokkaido university hospital, department of anesthesiology
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 Hokkaido university hospital
Address North 14, West 5, Kita-ku, Sapporo
Tel 011-706-7636
Email katsuhiro.aikawa@med.hokudai.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 北海道大学病院(北海道)/ Hokkaido university hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 20 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 10 Day
Date of IRB
2020 Year 05 Month 01 Day
Anticipated trial start date
2020 Year 05 Month 20 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the efficacy of modified-TAPA in the anterior branch and lateral cutaneous branch separately, pinprick tests are performed at the points below;
Anterior branch: between the vertical line through umbilicus and lateral edge of rectus abdominis muscle.
Lateral cutaneous branch: mid-axillary line.

Management information
Registered date
2020 Year 05 Month 02 Day
Last modified on
2020 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045968

Research Plan
Registered date File name
2020/05/09 M-TAPA研究計画書 ver 2.3.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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