UMIN-CTR Clinical Trial

Basic information
Public title	The analgesic efficacy of constant fentanyl infusion and IV acetaminophen with transversus abdominis plane block in thoracoscopic esophagectomy: a randomized controlled trial.
Acronym	The analgesic efficacy of constant fentanyl infusion and IV acetaminophen with transversus abdominis plane block in thoracoscopic esophagectomy: a randomized controlled trial.
Scientific Title	The analgesic efficacy of constant fentanyl infusion and IV acetaminophen with transversus abdominis plane block in thoracoscopic esophagectomy: a randomized controlled trial.
Scientific Title:Acronym	The analgesic efficacy of constant fentanyl infusion and IV acetaminophen with transversus abdominis plane block in thoracoscopic esophagectomy: a randomized controlled trial.
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigated the possibility that continuous intravenous fentanyl and IV acetaminophen with transversus abdominis plane block could replace epidural anesthesia in thoracoscopic esophageal surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical Rating Scale (NRS) at postoperative day 1 and 3 and 5.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Epi group : The epidural catheter is inserted between the 8th and 9th vertebrae. 100 ml of 0.25% levobupivacaine, 20 ml of fentanyl, and 80 ml of saline are infused continuously at 2-6 ml/hr. After completion of the medication, 100 ml of 0.25% levobupivacaine and 100 ml of saline are added and continued until the 5POD.
Interventions/Control_2	TAP+FA group : Intraoperative transversus abdominis plane block is performed with 40 ml of 0.5% levobupivacaine. Fentanyl IV-PCA (0.025mg/ml, lockout time 10 min) and IV acetaminophen 1000 mg every 6 hours are administered immediately before the end of surgery and continued until the 5POD.
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	Male and Female
Key inclusion criteria	1) Patients with esophageal cancer who are hospitalized or attending the Department of Gastroenterology and General Surgery, Showa University Hospital, and who have undergone radical thoracoscopic subtotal esophagectomy 2) Patients whose age at the time of consent acquisition is between 20 and 75 years old. 3) Patients who have given written consent to participate in this study.
Key exclusion criteria	(1) Patients with contraindications to the administration of levobupivacaine, fentanyl, or acetaminophen. (2) Patients who are at risk for epidural anesthesia catheter insertion or who have difficulty in insertion. (3) Patients who have difficulty in interviewing for postoperative pain assessment (dementia, postoperative intubation status, etc.). (4) Patients with serious hepatic, renal, or cardiac disorders that may affect the safety assessment of the drug. 5) Patients with additional painful procedures such as insertion of additional thoracic drains in the postoperative course, or with postoperative complications that affect postoperative pain. (6) Patients who have been administered anticoagulants before surgery. (7) Patients deemed ineligible by the research physician.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tomotake Middle name Last name Ariyoshi
Organization	SHOWA University
Division name	General and Gastroenterological Surgery
Zip code	1428555
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	0337848541
Email	tariyoshi@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Tomotake Middle name Last name Ariyoshi
Organization	SHOWA University
Division name	General and Gastroenterological Surgery
Zip code	1428555
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	0337848541
Homepage URL
Email	tariyoshi@med.showa-u.ac.jp

Sponsor
Institute	SHOWA University
Institute
Department

Funding Source
Organization	SHOWA 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	Showa University Medical Ethics Organization
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
Tel	0337848129
Email	m-rinri@ofc.showa-u.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	2021 Year 08 Month 10 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	2020 Year 08 Month 10 Day
Date of IRB	2021 Year 05 Month 07 Day
Anticipated trial start date	2021 Year 08 Month 11 Day
Last follow-up date	2023 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	2021 Year 08 Month 10 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051379