UMIN-ICDS 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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Gynecologic diseases such as uterine malignancies, uterine fibroids, and adenomyosis

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

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

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

Numbered container method

Intervention

No. of arms

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

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

Email

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

Email

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

Email

ino_rinri@naramed-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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/icdr_e/ctr_view.cgi?recptno=R000049412