UMIN-CTR Clinical Trial

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
Institute	Department of Anesthesiology, Nara Medical University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046907