UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038104 |
|---|---|
| Receipt number | R000042859 |
| Scientific Title | A randomized non-inferiority controlled trial of postoperative analgesic effect of epidural anesthesia and rectus sheath block in laparoscopic surgery |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2022/04/06 09:55:07 |
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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
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
y.owada@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042859
