Aim: The effect of interapitonial bupivacaine on postoperative pain in laparoscopic colorectal surgery. Design: a randomized, Double-blind, single-center, phase II clinical trial. Patients undergoing laparoscopic colorectal 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. The main inclusion criteria included patients undergoing laparoscopic colorectal surgery. Exclusion criteria included patients with a history of analgesics (narcotic or non-narcotic) 24 hours before surgery. Patients were divided into two groups bupivacaine and normal saline. The main outcome variables: Pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071716151N5
Registration date:2017-08-24, 1396/06/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-24, 1396/06/02
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
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
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 colorectal surgery
Public title
Effect of interapitonial bupivacaine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing laparoscopic colorectal surgery. 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.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Ethics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.iums.rec.1395.135553
Health conditions studied
1
Description of health condition studied
Colorectal Surgery
ICD-10 code
S36.5
ICD-10 code description
Injury of colon
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 prescribed.
Category
Prevention
2
Description
Control group: 50 cc normal saline is prescribed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr. Alireza Purnajafyan
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, 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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Alireza Purnajafyan
Position
Assistant Professor
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
a-pournajafian@tums.ac.ir
Web page address
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
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
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 Farnaz Safakhah
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)