UMIN-CTR Clinical Trial

Basic information
Public title	A randomized non-inferiority controlled trial of postoperative analgesic effect of epidural anesthesia and rectus sheath block in laparoscopic surgery
Acronym	A randomized non-inferiority controlled trial of postoperative analgesic effect of epidural anesthesia and rectus sheath block in laparoscopic surgery
Scientific Title	A randomized non-inferiority controlled trial of postoperative analgesic effect of epidural anesthesia and rectus sheath block in laparoscopic surgery
Scientific Title:Acronym	A randomized non-inferiority controlled trial of postoperative analgesic effect of epidural anesthesia and rectus sheath block in laparoscopic surgery
Region	Japan

Condition
Condition	Patients who received either laparoscopic gastrectomy or laparoscopic colectomy.
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to examine whether a single rectus sheath block is not inferior to continuous epidural anesthesia as postoperative analgesia for patients who have undergone either laparoscopic gastrectomy or laparoscopic colectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain scale (Numerical Rating Scale) when coughing 24 hours after surgery
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Epidural anesthesia group Before inducing anesthesia, perform catheter placement at the 9th to 11th thoracic vertebrae levels. Administer 0.375% ropivacaine epidurally at the start of wound closure. Patient-controlled epidural analgesia (PCEA) starts at the end of surgery. The drug solution is 0.2% Anapain and 3 mcg / mL fentanyl. Settings: Dosing rate 4 mL / h, bolus administration 2 mL, dosing interval 15 minutes or more, maximum one-time bolus administration 4 times.
Interventions/Control_2	Rectus sheath block group After the introduction of anesthesia, before the start of surgery. At the umbilical level, 15 mL of 0.375% Anapane is administered under echo guide.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients scheduled to undergo laparoscopic gastrectomy or laparoscopic colorectal resection of 6 cm or less where the wound is continuous with the umbilicus in addition to the port hole. Age: 20 years old and younger than 80 years old at the time of obtaining consent ASA-PS (American Society of Anesthesiologists physical status): 1-3 Patients who have received sufficient explanation for participation in this study, and who have fully understood and agreed to the document by their own will.
Key exclusion criteria	Antiplatelet / anticoagulant therapy There is a decrease in platelet count (80,000 <mcL), blood coagulation ability abnormality (aPTT> control value + 10 seconds or PT (%) <50%) History of spine surgery There is an allergy to the anesthetic used Weight less than 40 kg BMI> 30 kg / m2 Patients whose pain is difficult to evaluate (psycho-neuropathy, dementia, restlessness, etc.) Use regular painkillers Liver dysfunction (AST or ALT> 100 IU / L) Renal dysfunction (eGFR <50 mL / min / 1.73m2)
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Owada
Organization	University of Tsukuba
Division name	Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
TEL	029-853-3221
Email	y.owada@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Owada
Organization	University of Tsukuba
Division name	Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3221
Homepage URL
Email	y.owada@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba
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	Tsukuba Clinical Research & Development Organization
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	029-853-3914
Email	t-credo.adm@un.tsukuba.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	2019 Year 09 Month 26 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	80
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	2019 Year 09 Month 18 Day
Date of IRB	2019 Year 10 Month 10 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2021 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042859