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Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery

Protocol summary

Summary
Due to the importance of patients’ pain after laparoscopic surgeries, this study will be conducted to compare the effectiveness of intraperitoneal bupivacaine, acetazolamide, and placebo on pain relief after laparoscopic cholecystectomy surgery. Patients admitted to Rasool Akram hospital with physical status I or II of the ASA system (American Society of Anesthesiologists); aged 20 to 60 years; and who is candidate for laparoscopic cholecystectomy surgery due to gallstones in 2015 will be included in study. Patients who do not consent to be included in the study, patients with bile duct problems, and who has acute cholecystitis will be excluded. Patients will be divided into three groups (each containing 20 patients) using block randomization system with foursome blocks. Group one will receive bupivacaine, Group two will receive intravenous acetazolamide, and Group three will receive intravenous saline as placebo. After surgery, patients' pain by visual analoge scale as well as paracetamol usage will be assessed. The mentioned parameters will be assessed at 1, 4, 8, 12 and 24 hours after surgery with a blind doctor. At the end, all information analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032733159N1
Registration date: 2017-06-06, 1396/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Alireza Negahi
Name of organization / entity
Iran university of medical sciences, Rasool Akram hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2215
Email address
negahi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
iran university of medical sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery
Public title
Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having physical status I or II of the ASA system (American Society of Anesthesiologists); aged 20 to 60 years; who were candidate for laparoscopic cholecystectomy surgery due to gallstone. Exclusion criteria: Patients who do not consent to be included in the study; bile duct problems; acute cholecystitis; lack of ability to understand and use visual analogue scale (VAS); experience of sensitivity to NSAIDs and local anesthetics; class III and IV of ASA system; patients with choledocolitiasis; and drain in situ.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Iran University of Medical Sciences, Hemat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
1394 8623215562

Health conditions studied

1

Description of health condition studied
Calculus of gallbladder without cholecystitis
ICD-10 code
K80.2
ICD-10 code description
Cholecystolithiasis Cholelithiasis Colic (recurrent) of gallbladder Gallstone (impacted) of: cystic duct gallbladder unspecified or without cholecystitis

Primary outcomes

1

Description
pain
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
visual analog scale

2

Description
paracetamol usage
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
according to patient documents

Secondary outcomes

1

Description
heart rate
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
documentd by doctor

2

Description
systolic blood pressure
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
documentd by doctor

3

Description
diastolic blood pressure
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
documentd by doctor

4

Description
respiratory rate
Timepoint
just after surgery then 1, 4, 8, 12, and 24 hour after that
Method of measurement
documentd by doctor

Intervention groups

1

Description
intraperitoneal and local bupivacaine 0.5%. The maximum dose was 2 mg per kilogram. At the end of surgery and just one time
Category
Prevention

2

Description
0.5 mg per kg intravenous acetazolamide Once at the end of the surgery
Category
Prevention

3

Description
2 cc intravenous saline as placebo Once at the end of the surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital, Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Mr Adel
Street address
Iran University of Medical Sciences, Hemmet highway, Tehran
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 of 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
Surgery ward, Rasool Akram hospital
Full name of responsible person
Dr Alireza Negahi
Position
professor of general surgery
Other areas of specialty/work
Street address
Rasool Akram hospital, Niayesh street, Satarkhan avenue, Tehran
City
Tehran
Postal code
Phone
+216 4352215
Fax
Email
arnegahi@gmail.comh.vaseghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Surgery ward, Rasool Akram hospital
Full name of responsible person
Dr Alireza Negahi
Position
Professor of general surgery
Other areas of specialty/work
Street address
Rasool Akram hospital, Niayesh street, Satarkhan avenue, Tehran
City
Tehran
Postal code
Phone
+216 4352215
Fax
Email
Negahi.a@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasool Akram hospital
Full name of responsible person
Hamed Vaseghi
Position
Resident of general surgery
Other areas of specialty/work
Street address
Rasool Akram hospital, Niayesh street, Satarkhan avenue, Tehran
City
Tehran
Postal code
Phone
+216 4352215
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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