Aim of this study is evaluation of intraperitoneal marcaine effect in decreasing of pain after surgery.In this study patients with BMI more than 40 without exclusion criteria are entering in assessment.This survey is done randomized clinical trial.patients are allocated in two groups with balanced bloc randomization.In intervention group patients take 30 ml intraperitoneal marcaine that instillate on spleen;stomach;diapheragm.Both groups take analgesic(1g every 6 hour intravenous acetaminophen&every 8 hour suppository diclofenac NA).Pain is recorded at 6&12&24 hours after operation with NRS questionnaire.Results between two groups are compared.Becuase no surgeon no patients know which one recieved intraperitoneal marcaine when questionnare filling,study is double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120329181N4
Registration date:2017-02-09, 1395/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaid Beheshti Medical University;Tehran;Iran
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-23, 1395/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of intraperitoneal marcaeine instillationin control of pain after laparascopic sleeve gastrectomy
Public title
Anti-pain effect assessment of intraperitoneal marcaine after laparoscopic sleeve gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
BMI more than 40
Exclusion criteria
Untreatable cardiopulmonary disease;untreated addiction;untreated psychologic disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commity of Shahid Beheshti University of Medicasl Sciences
Street address
Daneshju Avenue Velenjak
City
Tehran
Postal code
Approval date
2016-11-29, 1395/09/09
Ethics committee reference number
ir.sbmu.retech.rec.1395.552
Health conditions studied
1
Description of health condition studied
Morbid Obesity
ICD-10 code
E66.8
ICD-10 code description
Other Obesity
Primary outcomes
1
Description
Pain
Timepoint
6,12.24 hour after operation
Method of measurement
Pain scaling criteria in NRS
2
Description
Hospital stay time
Timepoint
once
Method of measurement
Patient record
Secondary outcomes
1
Description
Nosocomial infection
Timepoint
First of study
Method of measurement
Report during 30 days
Intervention groups
1
Description
1g acetaminophen intravenous every 6 hour and
Diclofenac suppository every 8 hour in control group
Category
Treatment - Drugs
2
Description
30 cc Intraperitoneal marcaine instillation end of operation and 1g Acetaminophen every 6 hour and Diclofenac suppository every 8 hour in intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour Alamdari
Street address
Saadat Abad Modarres Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical sciences
Full name of responsible person
Nasser Malekpour Alamdari
Street address
Velenjak Daneshju avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical sciences
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
Shahid Beheshti University of Medical Sceinces
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Modarres Hospital Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2207 4087
Fax
Email
nassermalekpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Modarres Hospital Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2207 4087
Fax
Email
nassermalekpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Saadat Abad;Modarres Hospital
City
Tehran
Postal code
Phone
+98 22074087
Fax
Email
nassermalekpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)