UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040296 |
|---|---|
| Receipt number | 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 | 2021/07/24 23:45:59 |
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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 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
1. Gynecologic laparoscopic surgery cases undergoing modified-TAPA in addition to general anesthesia at Hokkaido university hospital.
2. 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 thoracotomy or laparotomy
8. Insufficient recovery of consciousness at 2 hours after surgery
9. Unexpected prolongation of surgical time ( > 6 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
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
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
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
The median (IQR) highest sensory level was T7 (T5-8) in the anterior and T9 (T7-10) in the lateral area. Sensory loss was not observed in the lateral area in five patients. The median (IQR) number of blocked dermatomes was 5 (7-4) in the anterior and 4 (5-2) in the lateral area (Figure 2).
Results date posted
| 2021 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 20 | Day |
Baseline Characteristics
Participant flow
Adverse events
Not observed.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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: within 5 cm from the vertical line through umbilicus.
Lateral cutaneous branch: mid-axillary line.
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045968
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/10/10 | M-TAPA研究計画書 ver 2.5.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
