UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002664 |
|---|---|
| Receipt number | R000003244 |
| Scientific Title | The Analgesic Efficacy of Transverse Abdominal Plane Block for Laparoscopic Surgery among Japanese Patients: a Randomized Controlled Trial. |
| Date of disclosure of the study information | 2009/10/24 |
| Last modified on | 2010/05/07 14:30:40 |
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Basic information
Public title
The Analgesic Efficacy of Transverse Abdominal Plane Block for Laparoscopic Surgery among Japanese Patients: a Randomized Controlled Trial.
Acronym
Transverse Abdominal Plane Block for Laparoscopic Surgery
Scientific Title
The Analgesic Efficacy of Transverse Abdominal Plane Block for Laparoscopic Surgery among Japanese Patients: a Randomized Controlled Trial.
Scientific Title:Acronym
Transverse Abdominal Plane Block for Laparoscopic Surgery
Region
| Japan |
Condition
Condition
Cholecystitis, Ovarian cyst
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the analgesic efficacy of transverse abdominal plane (TAP) block for laparoscopic cholecystectomy, ovarian cystectomy,and salpingo-oophorectomy .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
#Postoperative pain at 30min and 24 hours after surgery using Numerical Rating Scale (NRS).
#Intra- and postoperative dose of narcotic analgesics,
#Time from surgery to first analgesics use.
# Postoperative dose of NSAIDs and acetaminophen.
#Postoperative symptoms (nausea, vomiting)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
TAP block group: after induction of standard general anesthesia, echo-guided TAP block will be performed. The anesthesiologist who performs TAP block will be different from the one who inducts and maintains general anesthesia.
During the TAP block procedure, everyone except the TAP blocker and a nurse who assists the TAP blocker will leave the operation room.
The doctor who assesses the patients' postoperative pain, symptoms, and analgesic dose will be different from the anesthesiologist who inducts and maintains general anesthesia, and the TAP blocker.
Duration of Intervention;
From October 21, 2009 to December 31, 2009.
Interventions/Control_2
Control group: Same preparation of TAP block will be proceeded (disinfection of abdominal skin, abdominal description by echography, etc.) after everyone except the TAP blocker and a nurse who assists the TAP blocker leaves the operating room.
No injection will be given to the control group patients.
The doctor who assesses the patients' postoperative pain, symptoms, and analgesic dose will be different from the anesthesiologist who inducts and maintains general anesthesia, and the TAP blocker.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
# Patients undergoing laparoscopic cholecystectomy, ovarian cystectomy, and salpingo-oophorectomy
# Scheduled surgery
# Patients whose physical status classification of America Society of Anesthesiologists (ASA) is 1 or 2.
# Those who gives written informed consent.
Key exclusion criteria
# Those who have allergic history against local anesthetic drugs (amide type)
# The cases that are converted to open surgery.
# Those who are prescribed narcotic analgesics or NSAIDs preoperatively.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ohwada |
Organization
St. Luke's International Hospital
Division name
Department of Anesthesiology
Zip code
Address
9-1 Akashi-cho Chuo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Luke's International Hospital
Division name
Department of Anesthesiology
Zip code
Address
TEL
03-3541-5151
Homepage URL
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Luke's International Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Clinical Epidemiology,
St. Luke's Life Science Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 10 | Month | 24 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 24 | Day |
Last modified on
| 2010 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003244
