UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002664
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute St. Luke's International Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.