Background and Objectives: Postoperative pain after open cholecystectomy is one of the several factors that led to numerous complication and increases in mortality, morbidity. Multi-modal pre-emptive analgesia can help in controlling the pain via different mechanisms. This study intends to determine if this method could reduce post operative pain and complications as well as the amount of post operative analgesics requirements. Design: Sixty patients, who are candidate for open Cholecystectomy, will be recruited. Main inclusion criteria are patients under going open open Cholecystectomy and main exclusion criteria are history of addiction, hypochodriasis, and coagulation disorders. After providing written consent form, they will be randomly divided into the two groups: Study group will undergo four types of multi-modal pre-emptive analgesia (Diclofenac suppository 100 mg, Clonidine 0.2 mg half an hour before surgery, Ketamine 50 mg IV after induction of anaesthesia, infiltration of Bupivacaine 0.25% at the site of incision), while the control group will receive only one type of modality (infiltration of Bupivacaine 0.25% at the site of incision) plus placebo. At the end of the study two groups will be compared in terms of pain and analgesic consumption at various times after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712291772N2
Registration date:2010-05-31, 1389/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-31, 1389/03/10
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz medical university
Expected recruitment start date
2009-05-01, 1388/02/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multimodal Preincisional Early Premedication to Prevent Pain After Cholecystectomy
Public title
Post operative pain management
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: age from 20 to 60 people who are going to have open chlecyctectomy; Exclusion criteria : Coagulopathty, Refuse to participate, Addiction, hypochonderiasis
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
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
Impact on reducing opium use in the ward
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz medical university, reseach ethical committee
Street address
Tabriz medical university
City
Tabriz
Postal code
5167718113
Approval date
2009-03-29, 1388/01/09
Ethics committee reference number
5/4/174
Health conditions studied
1
Description of health condition studied
Cholecystitis and cholelithiasis
ICD-10 code
K80.1, K80
ICD-10 code description
Calculus of gallbladder with other cholecystitis and Other cholelithiasis
2
Description of health condition studied
opioid consumption
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
2, 4, 6, 12, 24, and 48 hours after operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid consumption
Timepoint
2, 4, 6, 12, 24, and 48 hours after operation
Method of measurement
Total dose
Intervention groups
1
Description
Control group: instead of Diclofenac, Clonidine and Ketamine they received placebo before the operation, but the surgical site infiltrated with Bupivacaine 0.25% before incision
Category
Placebo
2
Description
Intervention group received Diclofenac suppository 100 mg, Clonidine 0.2 mg half an hour before surgery and Ketamine 50 mg IV after induction of anesthesia. Site of Incision were infiltrated before the incision with Bupivacaine 0.25%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital Tabriz medical University
Full name of responsible person
Dawood Aghamohammadi
Street address
Tabriz ,Imam Reza HHospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz medical university
Full name of responsible person
Dawood Aghamohammadi
Street address
Tabriz medical university
City
Tabriz
Grant name
طرح تحقیقاتی
Grant code / Reference number
88/2/12
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz medical university
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
Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant professor
Other areas of specialty/work
Street address
Daneshgah Avenue
City
Tabriz
Postal code
5167718113
Phone
+98 41 1381 8940
Fax
+98 41 1381 8940
Email
aghamohammadid@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesia Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshghah avenue / Imam Reza Hospital
City
Tabriz
Postal code
5167718113
Phone
+98 41 1381 8940
Fax
+98 41 1381 8940
Email
aghamohammadid@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital / Tabriz medical university
City
Tabriz
Postal code
5167718113
Phone
+98 41 1381 8940
Fax
+98 41 1381 8940
Email
aghamohammadid@tbzemed.ac.ir
Web page address
www.tbzemed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)