Aim: The effect of intrapritoneal bupivacaine on postoperative pain in laparoscopic bariatric surgery.
Design
Design: a randomized, Double-blind, single-center, phase II clinical trial.
Settings and conduct
Patients undergoing laparoscopic bariatric(sleeve, bypass, minibypass) surgery are divided into two groups: bupivacaine and normal saline for washing the cutting sites and anastomosis. Pain score will be recorded during the first 24 hours of operation.
Participants/Inclusion and exclusion criteria
The main inclusion criteria included patients undergoing laparoscopic bariatric surgery with age 17-60 years with BMI>40 and ASA 2.
Exclusion criteria included patients with a history of analgesics (narcotic or non-narcotic) 24 hours before surgery.
Intervention groups
Patients were divided into two groups bupivacaine and normal saline.
Main outcome variables
The main outcome variables: Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140109016151N6
Registration date:2018-09-22, 1397/06/31
Registration timing:registered_while_recruiting
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interapitonial bupivacaine on postoperative pain in laparoscopic bariatric surgery
Public title
effect of interapitonial bupivacaine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: patients undergoing laparoscopic bariatric surgery with BMI>40 .
With age 17-60 years.
ASA 2.
Exclusion criteria:
Exclusion criteria: patients with history of analgesics (narcotic or non-narcotic) 24 hours before surgery.
Drug or alcohol abuse or allergy to any of the drugs used in the study.
Chronic pain syndrome.
participants, principle investigator and healthcare providers (Physicians, nurses)
The person who visits the patients postop, does not have the slightest idea of whether the patient belongs to case or control groups and merely records the postop pain and opioid used for each patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411174017
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
2, 8 and 24 hours after surgery
Method of measurement
based on a visual scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 cc of 0.2% bupivacaine is prescibed.
Category
Prevention
2
Description
Control group: 50 cc normal saline is prescibed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr. Alireza Pournajafian
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Email
a-pournajafian@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Email
a-pournajafian@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Pournajafian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8894 6762
Fax
Email
a-pournajafian@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Purnajafyan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8894 6762
Fax
Email
a-pournajafian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Maryam Ghanbari Garekani
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8894 6762
Fax
Email
Maryam_ghanbari_65@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available