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Evaluation of Effect of Adding Ultrasound-Guided Paravertebral Block to Continuous Intravenous Analgesia in Patients Undergoing Laparotomy

Protocol summary

Summary
1) Objectives: Evaluation of effect of adding ultrasound-guided paravertebral block to continuous intravenous analgesia in patients undergoing laparotomy 2) Design: in this randomized clinical trial we will assign 21 patients for each group randomly. 3) Setting and Conduct: Paravertebral block will be applied postoperatively in the intervention group, intravenous analgesia will be administrated in patients of the both groups. During 48 hours of the study, one of our colleagues who is blinded to groups will gather and analyze the data. 4) Participants: Inclusion criteria: Patients with American Society of Anesthesiologists (ASA) I–III scheduled for upper abdominal laparotomy that ranged in age from 18–80 years. Exclusion criteria: contraindication to regional anesthesia ( preoperative hemostasis disorder or a local or general infection ), history of allergic reaction to local anesthetic , a past medical history of asthma, chronic renal failure or hepatic dysfunction, history of opium abuse; history of neurological, neuromuscular or psychological disorders and pregnancy 5) Interventions: Intervention Group: ultrasound-guided paravertebral block with ropivacaine hydrochloride 0.2% ( Naropin 10mg/ml, 10ml polyamp, ASTRAZENECA ) 20 cc for each side in T7-T8 level plus continuous intravenous analgesia filled with fentanyl ( Fentanyl, Abureyhan, Iran ) 20cc with 80cc normal saline with infusion rate of 4ml/hour. Control Group: continuous intravenous analgesia filled with fentanyl 20 cc with 80 cc normal saline with infusion rate of 4 ml per hour. If patients experience “visual analogue scale” ( VAS ) above three, Pethidine HCL (0.5 mg per kg) will be administered intravenously during 48 after surgery. 6) Main Outcome Variable: “visual analogue scale”, total dosage of opioid

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201303227984N8
Registration date: 2013-05-04, 1392/02/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-04, 1392/02/14
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences, Tehran,Iran
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Adding Ultrasound-Guided Paravertebral Block to Continuous Intravenous Analgesia in Patients Undergoing Laparotomy
Public title
Effect of Paravertebral Block in Decreasing of Post Operative Pain of Laparotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: American Society of Anesthesiologists (ASA) I–III patients scheduled for upper abdominal laparotomy who ranged in age from 18–80 years. Patients were excluded if they exhibited a contraindication to regional anesthesia (preoperative homeostasis disorder or a local or general infection), history of allergic reaction to local anesthetic , a past medical history of asthma, chronic renal failure or hepatic dysfunction, history of opium abuse; history of neurological, neuromuscular or psychological disorders and pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 42
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
Ethics committee of Tehran University of Medical Sciences
Street address
Room 501, 5th Floor, Central Office of Tehran University of Medical Sciences, Keshavarz Bolvard
City
Tehran
Postal code
Approval date
2012-11-08, 1391/08/18
Ethics committee reference number
91.د.130.1927

Health conditions studied

1

Description of health condition studied
Patientis Undergoing Laparatomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post Operative Pain
Timepoint
2,6,12,24,48 Hour After Operation
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Total Dosage of Opioid
Timepoint
During 48 Hours after Surgery
Method of measurement
mg/ Nursing Report

Intervention groups

1

Description
Intervention Group: ultrasound-guided paravertebral block with ropivacaine hydrochloride 0.2% ( Naropin 10mg/ml, 10ml polyamp, ASTRAZENECA ) 20 cc for each side in T7-T8 level plus continuous intravenous analgesia filled with fentanyl ( Fentanyl, Abureyhan, Iran ) 20cc with 80cc normal saline with infusion rate of 4ml/hour.
Category
Treatment - Drugs

2

Description
Control Group: continuous intravenous analgesia (CIA) filled with fentanyl (Fentanyl, Abureyhan, Iran) 20cc with 80cc normal saline with infusion rate of 4ml/hour.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Farnad Imani
Street address
Niyayesh St, Sattarkhan St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
Tehran University of Medical Sciences , Ghods St, Keshavarz Blv,
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 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
Tehran University of Medical ciences
Full name of responsible person
Farnad Imani
Position
Associate Professor of Anesthesiology and Pain Medicine
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical enter, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
Phone
+98 216650905
Fax
Email
farimani@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor of Anesthesiology
Other areas of specialty/work
Street address
Depatment of Anesthesiology and Pain Medicine/ Rasoul Akram Medical Center
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
farimani@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeid Safari
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, Rasoul-Akram Medical Center, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
Phone
00
Fax
Email
drsafari.s@gmail.com
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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