UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045350 |
|---|---|
| Receipt number | R000050913 |
| Scientific Title | Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the mid-axillary line. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/03/10 08:42:18 |
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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 mid-axillary line.
Acronym
Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the mid-axillary line.
Scientific Title
Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the mid-axillary line.
Scientific Title:Acronym
Evaluation of anesthetized dermatomal range obtained by Modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) in the mid-axillary line.
Region
| Japan |
Condition
Condition
Gynecologic laparoscopic cases which were received M-TAPA puncturing at mid-axillary line in conjunction with general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In 2019, Tulgar et al. introduced novel approach for blocking anterior rami of the spinal nerves: Modified thoracoabdominal nervers block through perichondrial approach (M-TAPA). We have previously investigated the sensory area of M-TAPA, and revealed inconsistent effect in the lateral cutaneous nerves.
Considering the anatomy, we hypothesized that M-TAPA puncturing at the mid-axillary line, more lateral than the original technique, could provide steady sensory loss in the lateral area.
The purpose of this study is to investigate the sensory area obtained by M-TAPA puncturing at mid-axillary line, and to compare the result with original M-TAPA we previously demonstrated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
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 coughping 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
Gynecologic laparoscopic surgery patients undergoing mid-axillary M-TAPA in conjunction with general anesthesia in Hokkaido university hospital.
Key exclusion criteria
1. ASA-PS >=3
2. Pregnancy
3. Allergy to local anesthetics
4. Communication difficulty
5. Existing neuropathy
6. Body weight <=45 kg
7. BMI >35
8. Past history of thoracotomy or laparotomy
9. Insufficient recovery of consciousness at 2 hours after surgery
10. Unexpected prolongation of surgical time of >6 hours
11. 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
+81-11-706-7861
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
+81-11-706-7861
Homepage URL
katsuhiro.aikawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital, department of anesthesiology
Institute
Department
Personal name
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 clinical research and medical innovation center
Address
North 14, West 5, Kita-ku, Sapporo
Tel
+81-11-706-7061
crjimu@huhp.hokuda.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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | 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
This study is a prospective observational study to reveal the obtained sensory area of mid-axillary M-TAPA.
The result of this study will be compared with the historical data, which we have previously reported (doi: 10.1136/rapm-2021-102870).
Providing broader sensory loss of two dermatomal ranges in lateral area was regarded as clinically relevant for sample size calculation. Based on our data of M-TAPA, a sample size of 56 blocks (28 subjects) were required to a power of 0.8 and two-sided alpha of 0.05. Thus, we set the sample size as 60 blocks (30 subjects).
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050913
