Effect of Pre-Operative Administration of Acetazolamide on Post-Operational Shoulder Referred Pain and Abdominal Pain in Laparoscopic Cholecystectomy Candidates: a Randomized Placebo-Controlled Clinical Trial
The aim of this study is to compare the efficacy of pre-operative acetazolamide in relieving post-operational pain after laparoscopy. The present study is a randomized, double-blinded phase II clinical trial, with a parallel structure, that will be carried out in Alzahra Hospital during October 2017. 111 cholecystectomy patients that are qualified for this operation will participate in the present study. Since we want to evaluate the effect of acetazolamide dosage, subjects will be randomized into 0 (placebo), 5 and 10 mg/kg receiving groups through blocking and stratification methods. The drug in these groups is administered 1 hour before the laparoscopy operation in the form of tablet (acetazolamide or placebo). Afterwards, patients will be closely followed and Visual Analog Scale score and Modified Aldrete score will be assessed in them to estimate their pain and blood oxygen levels respectively, at certain times from the time of operation until the time of discharge.
Therefore, primary outcomes include: VAS score; and MAS score. Secondary outcomes include: time before requesting opioid, amount of opioid (opioid dose) used to deteriorate pain, distribution of pain locations and time before discharge from hospital.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081935778N1
Registration date:2017-10-29, 1396/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Kiarash Salimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 7840
Email address
kiarrach23@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-09-29, 1396/07/07
Expected recruitment end date
2017-10-10, 1396/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pre-Operative Administration of Acetazolamide on Post-Operational Shoulder Referred Pain and Abdominal Pain in Laparoscopic Cholecystectomy Candidates: a Randomized Placebo-Controlled Clinical Trial
Public title
Pre-Operative Acetazolamide Administration for Post-Operative Abdominal Pain Releif
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects must be candidates for laparoscopic cholecystectomy (ages 18 to 65)
Exclusion criteria:
Subject with a history of any hematologic disorders; chronic metabolic acidosis; chronic obstructive pulmonary disease; kidney transplantation; allergy to sufonamides; patients with present history of electrolyte disturbances; CNS dysfunction; renal failure or creatinine level higher than 2mg/dl; pregnancy; any liver diseases; or patients with ongoing diuretic treatment.
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:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Subjects will be randomized using bolcking and stratification methods.
Secondary Ids
1
Registry name
None
Secondary trial Id
None
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Biomedical Research of Isfahan Uiversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Postal code
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
ir.mui.rec.1395.3.142
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Abdominal Pain
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
VAS questionnaire
2
Description
Modified Aldrete Score
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
Physical examination for scoring; and pulse oxymetry
Secondary outcomes
1
Description
Time before requesting opioid
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
Timer
2
Description
Amount of opioid used to deteriorate pain
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
Report by resident
3
Description
Distribution of pain location
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
Physical Examination
4
Description
Time before discharge from hospital
Timepoint
first, second, and third 30 minutes within the operation, and first,second, and third 30 minutes within recovery, also at the time of discharge
Method of measurement
Timer
Intervention groups
1
Description
Intervention group 1:In this group patients will receive 10mg/Kg of Acetazolamide. Since estimated mean weight of patients is 75 Kg, each patient will be administered 6 halved 250-mg tablets (total of 750mg) 1 hour before laparoscopy operation.
Category
Prevention
2
Description
Control group:A placebo with identical appearance will be provided for each patient in this group. All patients in this group will be administered 6 halved placebo tablets 1 hour before laparoscopy operation.
Category
Placebo
3
Description
Intervention group 2:In this group patients will receive 5mg/Kg of Acetazolamide. Since estimated mean weight of patients is 75 Kg, each patient will be administered 3 halved 250-mg tablets (total of 375mg) and 3 halved placebo tablets 1 hour before laparoscopoy operation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Payman Soleimani
Street address
Alzahra Hospital, Soffeh St., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Parvin Sajedi
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
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 of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Payman Soleimani
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Heza Jarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 31 3625 7840
Fax
Email
kiarrach23@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Universtiy of Medical Sciences, Faculty of Medicine
Full name of responsible person
Parvin Sajedi
Position
Anesthesiology Practitioner
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 11 4428 9290
Fax
Email
kiarrach23@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Payman Soleimani
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 31 3625 7840
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)