Protocol summary

Summary
Patients undergoing laparoscopic cholecystectomy experience sever referred pain postoperatively. They usually require more analgesic consumption and long-term hospital stay, which consequently result in higher costs. Thus, this study is aimed to investigate the effect of acetazolamide and paracetamol on referred pain of candidate patients for laparoscopic cholecystectomy, and to find a cost-effective way to reduce pain. In a randomized, controlled, double blinded trial, 114 adult patients with uncomplicated cholelithiasis undergoing laparoscopic cholecystectomy will be evaluated with regard to postoperative referred pain. Patients are randomly assigned to 3 groups to receive 250 mg acetazolamide, 1 gr paracetamol or placebo. In case of any complications, such as ductal damage, bile leakage, biliary ascites or excessive bleeding during surgery, or if the surgeon has to insert a drain at the end of operation, then those patients are excluded from study. The postoperative pain will be assessed according to the location, intensity and type of pain, immediately before and after surgery, after return of consciousness, at the time of stay in post-operative care unit, during 24 hours stay in the ward and at the time of discharge. Also, the patients’ demographic data such as age and gender, the dose and kind of analgesic will be documented.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206108384N2
Registration date: 2012-06-25, 1391/04/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-06-25, 1391/04/05
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-05-21, 1392/02/31
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 referred postoperative pain after laparoscopic cholecystectomy
Public title
Comparison of the effect of acetazolamide and paracetamol on referred postoperative pain after laparoscopic gallbladder surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria 1- Patients candidates for laparoscopic cholecystectomy Excusion Criteria 1- Patients with pain disorder 2- Intraoperative complications such as cystic artery bleeding, leakage of bile into the peritoneal cavity 3- Postoperative complications such as bile duct injury, bile leakage, or biliary ascites. 4- Consumption of any narcotics and analgesics within 1 or 2 days before surgery. 5- Narcotics addicts 6- Contraindications to acetaminophen and acetasolamide, also lactose and starch (as components of the placebo) 7- Presence of inflammation, adhesions and excessive dissection which may prolong the operative time for more than 1 hours 8- The need for drain insertion
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
900337

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis

Primary outcomes

1

Description
Pain intensity
Timepoint
Immediately before and after surgery, after return of consciousness, at the time of stay in post-operative care unit, during 24 hours stay in the ward and at the time of discharge.
Method of measurement
Visual Analog Scale (VAS)

2

Description
Pain location
Timepoint
Immediately before and after surgery, after return of consciousness, at the time of stay in post-operative care unit, during 24 hours stay in the ward and at the time of discharge.
Method of measurement
Objectively

Secondary outcomes

1

Description
Analgesic consumption
Timepoint
Immediately before and/or after surgery and/or after return of consciousness and/or at the time of stay in post-operative care unit and/or during 24 hours stay in the ward and/or at the time of discharge
Method of measurement
mg

Intervention groups

1

Description
Acetazolamide tablet before induction of anesthesia & placebo of paracetamol at the end of surgery
Category
Treatment - Drugs

2

Description
Placebo tablet of acetazolamide before induction of anesthesia & Placebo Paracetamol at the end of surgery
Category
Treatment - Drugs

3

Description
Paracetamol infusion at the end of surgery & placebo tablet of acetazolamide before induction of anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Surgical Oncology Research Center
Full name of responsible person
Dr. Arash Peivandi Yazdi
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice chancellor for Research, Ghoreyshi Building, Daneshgah Street
City
Mashhad
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1802 2677
Fax
Email
surg.rc@mums.ac.ir; peivandia@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Profesor of Anesthesiology
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1802 2677
Fax
Email
surg.rc@mums.ac.ir; peivandia@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1802 2677
Fax
Email
surg.rc@mums.ac.ir; peivandia@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc

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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