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
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
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
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
