Protocol summary

Summary
This study is a clinical trial to compare the two methods of TAP BLOCK nerve blocks with Marcaine and Normal Saline on stress responses of 52 patients undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly divided into two groups. Inclusion criteria: Age of 18-60; BMI<30; Stage 1 and 2 ASA; Surgery time less than 2 hours; Absence of systemic disease such as (heart or lung disease and serious liver-Kidney disease); Absence of contraindications to epidural anesthesia (coagulopathies, infection at needle insertion site, the patient's lack of cooperation, absence of consent); Absence of any contraindications in performing Block; Absence of a history of immunosuppressive drugs and corticosteroids; Exclusion criteria for absence of a history of drug addiction and smoking: Failing to block; Incidence of complication during surgery and laparotomy for any reason; Prolongation of operation (more than 2 hours). The patients of two study groups, at the beginning of the surgery before anesthesia induction were put under TAP BLOCK with Marcaine in the intervention group and under normal saline in control group. The success rate of block will be studied in 2 ways: 1. Objective: Injection and deposition of the local anesthetic (Marcaine) between the IOM and TAM muscle layers will be determined under ultrasound-guide. 2 Subjective: Check the skin feel of the same area of the block in the epigastric and the umbilicus and the groin about 30 minutes after the block. In both groups before the induction of the patients, 3 blood samples of the patients will be taken, one before the start of induction and the second, 6 hours after extubation and the third, 24 hours after the surgery and in three of them, Blood Sugar, WBC, CRP, Cortisol IL-1 and TNF-α of these patients will be measured and compared. The postoperative pain in both groups of the patients will be measured and compared using the VAS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100824268N2
Registration date: 2015-11-19, 1394/08/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-19, 1394/08/28
Registrant information
Name
omid azimaraghi
Name of organization / entity
Department of Anesthesia
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2436
Email address
o-azimaraghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Research Department
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of TAP Block on stress responses in candidate patients for elective laparoscopic cholecystectomy surgery in Shariati hospital -1393
Public title
Comparison of the effect of Nerve Block with Marcaine and Normal Saline on stress response in patients undergoing general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-60 years, BMI<30, Stage 1 and 2 ASA, Surgery time less than 2 hours; Absence of systemic disease such as (heart or lung disease and serious liver-Kidney disease); Absence of contraindications to epidural anesthesia (coagulopathies, infection at needle insertion site, the patient's lack of cooperation, absence consent); Absence of any contraindications to perform Block; Absence of a history of immunosuppressive and corticosteroid drugs; Absence of a history of drug addiction and smoking. Exclusion criteria: Failing to block, Incidence of complications during surgery and laparotomy for any reason, Prolongation of operation (more than 2 hours)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
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
Vice Chancellor For Research of University, Tehran University of Medical Sciences
Street address
Medical School, Tehran University of Medical Sciences, Poursina Street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.TUMS.REC.1394.925

Health conditions studied

1

Description of health condition studied
General Anesthesia
ICD-10 code
T41.1، T41
ICD-10 code description
Intravenous Anesthetics, Other and Unspecified General Anesthetics, Local Anesthetics

Primary outcomes

1

Description
pain
Timepoint
Immediately, 6, 12, 24 hours after discharge from recovery
Method of measurement
Visualized Analogue Scale

2

Description
The Subjective Success Rate of Block
Timepoint
30 minute
Method of measurement
Check the skin sensation of the same area of block in the epigastric and umbilical and groin

3

Description
Objective success rate of blockage for anesthesia by injection and deposition of the sediment material (Marcaine) between the layers of muscle (IOM and TAM)
Timepoint
During of surgery
Method of measurement
Ultrasound sonography

Secondary outcomes

1

Description
Blood Sugar ,WBC , CRP , Cortisol, TNF-α and IL-1 level of serum
Timepoint
Before induction of anesthesia and 6 and 24 hours after extubation of patient
Method of measurement
Blood Exam

Intervention groups

1

Description
Nerve block with TAP Methods with Marcaine in the intervention group
Category
Prevention

2

Description
Nerve block with TAP Methods with Normal Saline in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr Farhad Rahimi
Street address
Dr Shariati Hospital, Jalal Al Ahmad Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research of University, Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh, Vice Chancellor For Research of Tehran University of Medical Sciences
Street address
206 Room, First Floor, Medical School, Tehran University of Medical Sciences, Keshavarz Boulevard, Amir Abad, 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 University, Tehran 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
Anesthesiology Department, Dr Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Farhad Rahimi
Position
Assistant
Other areas of specialty/work
Street address
Dr shariati Hospital, Jalal Al Ahmad Street, Northen Kargar Street, Tehran,
City
Tehran
Postal code
Phone
+98 21 8490 1001
Fax
Email
Rahimi1984@gmail.com dFarha
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology department, Dr Shariati Hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8822 0032
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology Department, Dr Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Farhad Rahimi
Position
Anesthesia Assistant
Other areas of specialty/work
Street address
Dr shariati Hospital, Jalal Al Ahmad Street, Northen Kargar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8490 1001
Fax
Email
Rahimi1984@gmail.com dFarha
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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