Comparison of acetazolamide and paracetamol on postoperative referral pain in patients undergoing laparoscopic cholecystectomy
Design
A double-blinded, parallel-group clinical trial with random sampling and allocation in 2 groups of intervention and 1 group control .
Settings and conduct
A recent study was conducted on 114 patients undergoing laparoscopic cholecystectomy and based on their purpose. The patients were divided into 3 groups: acetazolamide, paracetamol and placebo.
Participants/Inclusion and exclusion criteria
Inclusion: All patients undergoing laparoscopic cholecystectomy
Exclusion:
1. Patients with an underlying disease with impaired sense of pain . Exit of natural pathology including bleeding from the cystic artery or expelling bile into the peritoneum. The incidence of any complications associated with surgery, including duct injury, bile ducts, even if detected after discharge and during the fallopian occlusion. Receive analgesic and analgesic drugs within 24 and 48 hours, 5. Drug addict, 6. Contraindications of acetaminophen, acetazolamide, lactose and starch, 7. The presence of inflammation based on the surgeon's observations during surgery, in which the adhesions and dyslexia are over-regulated
8. Patients in need of drainage
Intervention groups
1. acetazolamide group: received acetazolamide before induction of anesthesia + administration of placebo paracetamol
2. paracetamol group: 1 gram paracetamol administration at the end of surgery for slow infusion over 15 minutes plus 100 cc of crystalloid solution + placebo before induction of anesthesia
3. placebo group:Placebo : acetazolamide)before induction of anesthesia + administration of placebo at the end of surgery.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039958N1
Registration date:2019-01-24, 1397/11/04
Registration timing:retrospective
Last update:2019-01-24, 1397/11/04
Update count:0
Registration date
2019-01-24, 1397/11/04
Registrant information
Name
Arash Peyvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
nrc@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acetazolamide and paracetamol on referral pains following laparoscopic cholecystectomy
Public title
Effect of acetazolamide and paracetamol on referral pain after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing laparoscopic cholecystectomy
Exclusion criteria:
Having a disease that causes pain in the sensation
Receiving analgesic and anti-inflammatory drugs within 48-48 hours
Drug addicts
Contraindications for acetaminophen, acetazolamide, lactose and starch (used in placebo)
The presence of inflammation based on surgical surgeries in a way that overlaps adhesions and dyslexia is more likely to last longer than an hour.
Patients Needed Dren
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to the control or intervention group by drawing a random number out of a bag.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be informed about which group they are in. Also, the data analyst will be blind to which group the participants are assigned
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashahd University of Medical Sciences
Street address
Ibn sina street Imam Reza Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
IR.MUMS.REC.1390.14
Health conditions studied
1
Description of health condition studied
referred postoperative painafter laparoscopic cholecystectomy
ICD-10 code
Z90.410
ICD-10 code description
Acquired total absence of pancreas
Primary outcomes
1
Description
Pain in cholecystectomy surgery by laparoscopy due to uncomplicated
Timepoint
Immediately before surgery, after surgery and after awakening, discharge from the recovery, the day after surgery, and upon discharge from the hospital
Method of measurement
Questionnaire based on purpose and patient view
Secondary outcomes
empty
Intervention groups
1
Description
The first group (acetazolamide group) received acetazolamide tablets 250 mg half an hour before induction of anesthesia plus 20 cc water + placebo administration Paracetamol (isotonic saline solution) at the end of the surgery half an hour
Category
Treatment - Drugs
2
Description
Control group: Administration of 1gr of paracetamol at the end of the surgical operation as a slow infusion over 15 minutes plus 100 cc of crystalloid solution + receiving placebo (acetazolamide) half an hour before induction of anesthesia with 20cc of water
Category
Treatment - Drugs
3
Description
Intervention group2: 1 gram paracetamol administered at the end of surgery for slow infusion in 15 minutes, plus 100 cc of crystalloid solution + placebo (acetazolamide) 0.5 hour before induction of anesthesia with 20cc water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Surgery Research Center
Full name of responsible person
Mahsa Rajaee
Street address
Iman Reza Square, Imam Reza Hospital, Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2677
Email
nrc@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
International Offic Administration Center (Qoreishi Building) ; Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
913
Phone
+98 51 3802 2677
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaee
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iman Reza Square, Imam Reza Hospital, Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2677
Email
nrc@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaee
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iman Reza Square, Imam Reza Hospital, Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2677
Email
nrc@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Rajaee
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Iman Reza Square, Imam Reza Hospital, Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2677
Email
nrc@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the questionnaire information is available
When the data will become available and for how long
After publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
The use of drugs to estimate pain relief after surgery
From where data/document is obtainable
Available in Google & Pubmed
What processes are involved for a request to access data/document