Effect of intraperitoneal irrigation with sodium bicarbonate versus normal saline on post-operative pain in patients who are candidate for elective laparotomy: a double blind randomized clinical trial
Objectives: to assess the effect of intraperitoneal irrigation with sodium bicarbonate versus normal saline on post-operative pain in patients who are candidate for elective laparotomy.
Design: double blind randomized clinical trial.
Setting and conduct: the eligible patients who are candidate for elective laparotomy and will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age 18 to 65 years old; candidate for elective laparotomy.
Exclusion criteria: loss of consciousness; heart failure; hemodynamic disorder; renal and hepatic and lung diseases; electrolyte imbalance.
Intervention group: intraperitoneal irrigation with sodium bicarbonate plus normal saline for 2 to 5 minutes during surgery.
Control group: intraperitoneal irrigation with normal saline for 2 to 5 minutes during surgery.
Primary outcome: pain at surgery site 12 and 24 hours post-operation using VAS.
Randomization: patients will be randomly assigned to intervention and control groups through drawing lot.
Blinding: patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612089014N138
Registration date:2016-12-09, 1395/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intraperitoneal irrigation with sodium bicarbonate versus normal saline on post-operative pain in patients who are candidate for elective laparotomy: a double blind randomized clinical trial
Public title
Effect of intraperitoneal irrigation with sodium bicarbonate versus normal saline on post-operative pain in patients who are candidate for elective laparotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65 years old; candidate for elective laparotomy.
Exclusion criteria: loss of consciousness; heart failure; hemodynamic disorder; renal and hepatic and lung diseases; electrolyte imbalance.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: patients will be randomly assigned to intervention and control groups through drawing lot.
Blinding: patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
IR.UMSHA.REC.1395.190
Health conditions studied
1
Description of health condition studied
laparotomy
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
pain at surgery site
Timepoint
12 and 24 hours post-operation
Method of measurement
using VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intraperitoneal irrigation with sodium bicarbonate plus normal saline for 2 to 5 minutes during surgery.
Category
Treatment - Drugs
2
Description
Control group: Intraperitoneal irrigation with normal saline for 2 to 5 minutes during surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Roohollah Hoseini
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Roohollah Hoseini
Position
Resident of Surgery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
Drhosseini81@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Hamid Reza Khorshidi
Position
Surgeon
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
Khorshidi _h2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)