UMIN-CTR Clinical Trial

Basic information
Public title	Effects of ultrasound-guided transversus abdominis plane block and rectus sheath block on stress hormone response after laparoscopic colon surgery
Acronym	Effects of ultrasound-guided peripheral nerve block on laparoscopic colon surgery
Scientific Title	Effects of ultrasound-guided transversus abdominis plane block and rectus sheath block on stress hormone response after laparoscopic colon surgery
Scientific Title:Acronym	Effects of ultrasound-guided peripheral nerve block on laparoscopic colon surgery
Region	Japan

Condition
Condition	colon tumor
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clarify the effect of ultrasound-guided transversus abdominis plane block and rectus sheath block on perioperative stress hormone response after laparoscopic colon surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Plasma epinephrine concentration on the morning of postoperative day 1 (POD1).
Key secondary outcomes	Visual Analog Scale pain score, occurrence of drowsiness, concentration of plasma norepinephrine, cortisol and IL-6, and additional analgesics usage on the morning of POD1.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Ultrasound-guided transversus abdominis plane block and rectus sheath block with levobupivacaine.
Interventions/Control_2	No ultrasound-guided 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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are scheduled for laparoscopic colectomy in Iwate Medical University Hospital with written informed consent agreement.
Key exclusion criteria	Contraindication for any drugs used during anesthesia, chronic pain under treatment, nerve disorder and psychiatric diseases.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Wakimoto
Organization	School of Medicine, Iwate Medical University
Division name	Department of Anesthesiology
Zip code	0208505
Address	19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
TEL	019-651-5111
Email	silkhat_mw@hotmail.com

Public contact
Name of contact person	1st name Masahiro Middle name Last name Wakimoto
Organization	School of Medicine, Iwate Medical University
Division name	Department of Anesthesiology
Zip code	020-8505
Address	19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
TEL	019-651-5111
Homepage URL
Email	silkhat_mw@hotmail.com

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Department of Anesthesiology, School of Medicine, Iwate Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	School of Medicine, Iwate Medical University
Address	19-1 Uchimaru, Morioka city, Iwate prefecture, Japan
Tel	019-651-5111
Email	imuctc@iwate-med.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	2015 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
Date of IRB	2016 Year 02 Month 10 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 07 Day
Last modified on	2022 Year 07 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021114