UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045111 |
|---|---|
| Receipt number | R000051379 |
| Scientific Title | The analgesic efficacy of constant fentanyl infusion and IV acetaminophen with transversus abdominis plane block in thoracoscopic esophagectomy: a randomized controlled trial. |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/10 15:47:16 |
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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
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
tariyoshi@med.showa-u.ac.jp
Sponsor or person
Institute
SHOWA University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051379
