Transversus abdominis plane (TAP) block is a recently introduced regional anesthesia technique which was used for postoperative pain reduction in some of the abdominal surgeries. Present study evaluated the efficacy of the TAP block on the post laparascopic cholecystectomy pain intensity and analgesic consumption.
Fifthy four patients were enrolled in three groups: TAP block with normal salin (group 1, n=18), TAP block with bupivacain (group 2, n=18) and TAP block with bupivacain plus sufentanil (group 3, n=18). The time to the first fentanyle request, fentanyl consumption in 24 hours following surgery, and postoperative pain intensity at the half, one, six, 12 and 24 hours following discharge of recovery were measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401255140N13
Registration date:2014-04-12, 1393/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Anesthesiology department, Shariati Hospital; investigator
Expected recruitment start date
2012-03-01, 1390/12/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectivness of transverse abdominal plane block in reducing post laparascopic cholecystectomy pain in Shariati hospital
Public title
The effectivness of transverse abdominal plane block in reducing post laparascopic cholecystectomy pain in Shariati hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; all candidates with laparascopic cholecystectomy; age between 20-65 years old; without any allergy to the drugs use in this study; addiction; without infection at the side of needle insertion; without contraandication for TAP block.
Exclusion criteria: any patients with surgical complication; and in cases which operation last more than 3 hours; the cases were excluded from study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee, Faculty of medicine of Tehran university of Medical Sciences
Street address
Tehran University of medical science
City
Tehran
Postal code
14117
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
436
Health conditions studied
1
Description of health condition studied
post-op pain
ICD-10 code
R52
ICD-10 code description
pain
Primary outcomes
1
Description
The first time of requesting opioid for releasing the pain from patient
Timepoint
0, 0.5, 1 , 6, 12, 24 hours after surgery
Method of measurement
Whole amount of opioid usage with PCA pomp in PACU recorded by an expert physician
Secondary outcomes
1
Description
Variation of the post-op pain
Timepoint
0, 1, 3, 6, 12, 24 hours after surgery
Method of measurement
Recording the pain score with the protocol of VAS system by an expert phycision
Intervention groups
1
Description
intervention groups
group 1: receive either 30 ml of bupivacaine 0.5% plus 2-ml normal salin, 16-ml in each side ( n=18 )
group 2: 30 ml of bupivacaine 0.5% plus 2 ml sufentanil, 16 ml in each side ( n=18)
at the end of surgical procedure
Category
Treatment - Drugs
2
Description
Control group: 32 ml of 0.9% normal salin 16 ml in each side (n=18), at the end of surgical procedure
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Shariati Hospital
Full name of responsible person
Dr Ali Movafegh
Street address
Anesthesiology department, Dr shariati hospital, Tehran University of medical science
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Vice Chancellor for research , Tehran University of Medical Sciences, North Kargar Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave.
City
Tehran
Postal code
14117
Phone
+98 21 8241 5723
Fax
+98 21 8241 5400
Email
ali.movafeg@gmail.com
Web page address
ali@movafegh.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Shariati Hosp, North Karegar Ave.
City
Tehran
Postal code
14117
Phone
+98 21 8241 5723
Fax
Email
ali.movafegh@gmail.com
Web page address
ali@movafegh.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gilda Barzin
Position
MD, resident of anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, tehran Iran
City
Tehran
Postal code
14117
Phone
+98 21 8241 5723
Fax
+98 21 8241 5400
Email
gildabarzin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)