Evaluation the effects of bilateral intrapleural infusion of Lidocaine and Fentanyl
versus Lidocaine for pain relief in Coronary Artery Bypass surgery patients
The goal of study is to evaluation the effects of bilateral intrapleural infusion of lidocaine and Fentanyl versus lidocaine for pain relief in CABG surgery.Inclusion criteria: EF≥30%; cratinine≤1.8; elective CABG; age 20 -60 years. exclusion criteria: EF< 30 %; cratinine>1.8; sensitivity to local anesthetics; addiction to opiums; bleeding more than 1000 ml/24h. After approval from university ethical committee and obtaining written consent from patients, the prospective randomized, double-blind clinical trial will be done on 130 patients 20 to 60 years undergoing coronary artery bypass surgery between 3 to 6 hours in the Tabriz Shahid Madani hospital.
At the end of the operation two-sided suction catheter will be placed into the pleural space. Patients will be divided in lidocaine and fentanyl group (group A) (65 patients) and lidocaine group (group B) (65 people) and at the end of surgery and ICU every 6 hours, 20 ml of lidocaine 0.75% + fentanyl 2mcg / kg in group A and 20 mL of lidocaine 0.75% in group B will be injected through the intraplural catheter. The pain in all patients will evaluate using (Visual analog scale VAS) every 2 hours . VAS and the type and total amount of analgesic drug consumption will be recorded. P value <0.05 was considered significant
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015112714728N2
Registration date:2015-12-12, 1394/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Kamran Shadvar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1994
Email address
shadvark@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of bilateral intrapleural infusion of Lidocaine and Fentanyl
versus Lidocaine for pain relief in Coronary Artery Bypass surgery patients
Public title
Evaluation the effects of bilateral intrapleural infusion of Lidocaine and Fentanyl
versus Lidocaine for pain relief in Coronary Artery Bypass surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: EF≥30%; cratinine≤1.8; elective CABG; age 20 -60 years
exclusion criteria: EF< 30 %; cratinine>1.8; history of plural desease; COPD; sensitivity to local anesthetics; addiction to opiums; drug habits to analgesics, calcium channel blockers, α2 agoniste; history of cardiac surgery and as a surgery complications such as aortic dissection, reoperation due to bleeding; bleeding more than 1000 ml/24h
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
93172
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R07.4
ICD-10 code description
Chest pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
every 2 hours
Method of measurement
VAS
Secondary outcomes
1
Description
Duration of ICU stay
Timepoint
After Intervention
Method of measurement
Hour
Intervention groups
1
Description
In intervention group: 20 ml of lidocaine 0.75% + fentanyl 2mcg/kg solution will be administered via intraplural catheter every 6 hours up to 24 hours.
Category
Treatment - Drugs
2
Description
In control group: 20 ml of lidocaine 0.75% solution will be administered via intraplural catheter every 6 hours up to 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Dr. Kamran Shadvar
Street address
Daneshgah st, Shahid Madani Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Magami
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Kamran Shadvar
Position
ICU Fellowship
Other areas of specialty/work
Street address
Shahid Madani Hospital, Daneshgah st.
City
Tabriz
Postal code
Phone
+98 41 3335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kamran Shadvar
Position
ICU Fellowship
Other areas of specialty/work
Street address
Shahid Madani Hospital, Daneshgah st.
City
Tabriz
Postal code
Phone
+98 41 3335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Kamran Shadvar
Position
ICU Fellowship
Other areas of specialty/work
Street address
Shahid Madani Hospital, Daneshgah st.
City
Tabriz
Postal code
Phone
+98 41 3335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)