UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057497 |
|---|---|
| Receipt number | R000065684 |
| Scientific Title | A comparative study of ultrasound-guided rectus sheath block and posterior transversus abdominis plane block versus local infiltration anesthesia and laparoscopy-guided transversus abdominis plane block for postoperative analgesia after laparoscopic colon resection |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2025/04/03 04:27:21 |
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Basic information
Public title
A comparative study of ultrasound-guided rectus sheath block and posterior transversus abdominis plane block versus local infiltration anesthesia and laparoscopy-guided transversus abdominis plane block for postoperative analgesia after laparoscopic colon resection
Acronym
A comparative study of ultrasound-guided rectus sheath block and posterior transversus abdominis plane block versus local infiltration anesthesia and laparoscopy-guided transversus abdominis plane block
Scientific Title
A comparative study of ultrasound-guided rectus sheath block and posterior transversus abdominis plane block versus local infiltration anesthesia and laparoscopy-guided transversus abdominis plane block for postoperative analgesia after laparoscopic colon resection
Scientific Title:Acronym
A comparative study of ultrasound-guided rectus sheath block and posterior transversus abdominis plane block versus local infiltration anesthesia and laparoscopy-guided transversus abdominis plane block
Region
| Japan |
Condition
Condition
Laparoscopic colon resection
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between ultrasound-guided rectus sheath block with posterior transversus abdominis plane block and local infiltration anesthesia with laparoscopy-guided transversus abdominis plane block in patients undergoing laparoscopic colon resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change over time in resting NRS score
Key secondary outcomes
NRS scores at 0, 1, 2, 3, 6, 12, and 24 hours postoperatively, length of hospital stay, opioid consumption, time required to perform each nerve block (including cleanliness time when using ultrasound equipment), and adverse events
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided rectus sheath block and posterior transversus abdominis plane block (each using 20 mL of 0.25% popscaine)
Interventions/Control_2
Local infiltration anesthesia to the umbilical region and laparoscopic transverse abdominal plane block (each using 20 mL of 0.25% popscaine)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adult patients (ASA-1 or 2) undergoing laparoscopic colon resection (excluding Miles procedure)
2.The patients obtained the written informed consent of participation into this study
Key exclusion criteria
Patients with BMI >35, coagulation dysfunction, severe liver or kidney dysfunction, allergy or intolerance to anesthetics, chronic pain syndrome, history of opioid use, local infection at the puncture site, and difficulty communicating
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesia
Zip code
8570134
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
TEL
0956492191
yoterao@nagasakih.johas.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesia
Zip code
8570134
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
TEL
0956492191
Homepage URL
yoterao@nagasakih.johas.go.jp
Sponsor or person
Institute
Department of Anesthesia, Nagasaki Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Rosai Hospital
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
Tel
0956492191
shom@nagasakih.johas.go.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
| 2025 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065684
