UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043336 |
|---|---|
| Receipt number | R000049412 |
| Scientific Title | Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in laparoscopic gynecological surgery - Comparison with the oblique subcostal transversus abdominis plane block : a pilot randomized controlled trial |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2024/01/29 11:43:20 |
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Basic information
Public title
Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in laparoscopic gynecological surgery - Comparison with the oblique subcostal transversus abdominis plane block : a pilot randomized controlled trial
Acronym
Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in laparoscopic gynecological surgery - Comparison with the oblique subcostal transversus abdominis plane block : a pilot randomized controlled trial
Scientific Title
Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in laparoscopic gynecological surgery - Comparison with the oblique subcostal transversus abdominis plane block : a pilot randomized controlled trial
Scientific Title:Acronym
Investigation of the efficacy by modified thoracoabdominal nerves block perichondrial approach (M-TAPA) in laparoscopic gynecological surgery - Comparison with the oblique subcostal transversus abdominis plane block : a pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Gynecologic diseases such as uterine malignancies, uterine fibroids, and adenomyosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The blockage of thoracoabdominal nerves through perichondrial approach (TAPA) is a recently described novel regional anesthesia method which potentially provides effective and extensive sensorial block of the thoracoabdominal region. The analgesic effect of M-TAPA in laparoscopic gynecological surgery and the transition of blood concentration of local anesthetics are compared with the oblique subcostal transversus abdominis plane block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality Recovery 15 (QoR-15) score at the day before surgery and 48 hours after surgery
Key secondary outcomes
Numerical rating scale (NRS) at 2/12/24/48 hours after surgery
Measurement of blood concentration of levobupivacaine at 15/30/45/60/120 minutes after block enforcement
Time to request the first bolus on the patient controlled analgesia after surgery
Frequency of non-opioid analgesic use
Occurrence of postoperative nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
modified thoracoabdominal nerves block through perichondrial approach
Interventions/Control_2
oblique subcostal transverse abdominis plane block
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
Patients scheduled laparoscopic hysterectomy 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
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 < 42 kg
BMI > 35
Visit restrictions due to prevention for COVID-19
Judged inappropriate by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuka |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijyo-cho, Kashihara, Nara
TEL
0744-22-3051
szk.tknr.0825@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuka |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijyo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
szk.tknr.0825@naramed-u.ac.jp
Sponsor or person
Institute
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
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
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/jcm13030712
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
46
Results
The primary outcome was changes in QoR-15 scores on postoperative days (POD) 1 and 2 from the preoperative baseline. Group differences (M-TAPA- OSTAPB) in mean changes from baseline in QoR-15 scores on POD 1 and 2 were -11.3 (95% confidence interval (CI), -24.9 to 2.4, standard deviation (SD), 22.8) and -7.0 (95% CI, -20.5 to 6.6, SD, 18.7), respectively.
Results date posted
| 2024 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female patients aged 20-75 years with an American Society of Anesthesiologists physical status of 1-2 who were scheduled for TLH with four abdominal ports were enrolled in this study.
Participant flow
Three months after the surgery, the electronic medical record was used to check the patient's condition and to check for adverse events.
Adverse events
Nothing
Outcome measures
The primary outcome was the changes in the QoR-15 scores on POD 1 and 2 from the preoperative baseline, calculating the group differences and SDs between M-TAPA and OSTAPB. The QoR-15 questionnaire is recommended for assessing postoperative patient comfort and pain in perioperative clinical trials. It consists of five domains related to quality of care: pain, physical comfort, physical independence, psychological support, and emotional state. The questionnaire used an 11-point NRS, with scores ranging from 0 (extremely poor recovery) to 150 (excellent recovery).
The secondary outcomes were resting and dynamic pain scores (NRS, 0-10) at 2 h after surgery, POD 1, and POD 2; the PClevo 15, 30, 45, 60, and 120 min after the initial intraoperative levobupivacaine bolus injection; comparison of the peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax) for levobupivacaine; procedure duration (from skin preparation to nerve block completion); and postoperative fentanyl consumption. The Cmax and Tmax values of levobupivacaine were directly recorded for each patient based on the measured values.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 03 | 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
Management information
Registered date
| 2021 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049412
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| Registered date | File name |
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