UMIN-ICDS Clinical Trial

Public title

Thoracoabdominal Sensory Block Distribution Following SEDIC Block for Lateral Abdominal Surgery: A Prospective Observational Study

Acronym

SEDIC-DIST Study

Scientific Title

Thoracoabdominal Sensory Block Distribution Following SEDIC Block for Lateral Abdominal Surgery: A Prospective Observational Study

Scientific Title:Acronym

SEDIC-DIST Study

Region

Japan

Condition

Robot-assisted partial nephrectomy, laparoscopic partial nephrectomy, laparoscopic adrenal surgery

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We performed a SEDIC block in patients undergoing robot-assisted or laparoscopic partial nephrectomy and laparoscopic adrenal surgery, and prospectively evaluated the postoperative thoracoabdominal wall sensory block distribution using a pinprick test, particularly clarifying the extent of sensory block in the area of the lateral cutaneous branches.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Measure the effective range of the SEDIC block using a pin-prick test.

Key secondary outcomes

Cold sensation tests
QoR-15 (the Quality of Recovery-15) before surgery and on postoperative days 1 and 2
NRS (Numerical Rating Scale) values on postoperative days 1 and 2
usage of analgesics up to 24 hours postoperatively
the occurrence of adverse events will be recorded

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients classified as 1 or 2 by the American Society of Anesthesiologists
Patients aged 20 years or older but under 85 years
Patients who provided written consent for this study

Key exclusion criteria

Patients undergoing emergency surgery applied for on the day of surgery
Patients who chronically use opioids
Patients allergic to local anesthetics
Patients who do not have the capacity to give consent
Patients with recognized coagulation abnormalities
Patients receiving antithrombotic therapy who do not have an adequate withdrawal period
Patients for whom sensory evaluation is difficult due to neurological disorders
BMI > 35
Weight < 50 kg
Surgery time > 6 hours
Patients deemed inappropriate as research subjects by the principal investigator

Target sample size

30

Name of lead principal investigator

1st name	Miki
Middle name
Last name	Umehara

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara City, Nara Prefecture

TEL

0744-22-3051

Email

k104465@naramed-u.ac.jp

Name of contact person

1st name	Miki
Middle name
Last name	Umehara

Organization

Nara Medical University

Division name

Department of Anesthesiology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara City, Nara Prefecture

TEL

0744-22-3051

Homepage URL

Email

k104465@naramed-u.ac.jp

Institute

Nara Medical University

Institute

Department

Personal name

Miki Umehara

Organization

Nara Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nara Medical University Ethics Committee

Address

840 Shijo-cho, Kashihara City, Nara Prefecture

Tel

0744-22-3051

Email

ino_rinri@naramed-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

奈良県立医科大学附属病院（奈良県）

Date of disclosure of the study information

2026

Year

03

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

17

Day

Date of IRB

Anticipated trial start date

2026

Year

04

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

From the date of implementation approval until March 31, 2028, adult patients scheduled for robot-assisted or laparoscopic partial nephrectomy and laparoscopic adrenal surgery at this facility will be targeted.
The patient will be enrolled after receiving an explanation about the study before surgery and providing written consent.
This study is a prospective observational study.
After induction of general anesthesia, bilateral SEDIC blocks will be performed under ultrasound guidance.
Two hours after surgery, a pinprick test will be performed on the T4-L1 skin segments to determine the area of effect.
As secondary evaluation items, a cold sensation test in the same area, QoR-15 (the Quality of Recovery-15) on preoperative day and postoperative days 1 and 2, NRS (Numerical Rating Scale) values on postoperative days 1 and 2, use of analgesics up to 24 hours postoperatively, and the occurrence of adverse events will be recorded.

Registered date

2026

Year

03

Month

18

Day

Last modified on

2026

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069767