Assessment of local bupivacain injection effect in comparison of placebofor relieving of acute post - thoracotomy pain in patients who undergoing thoracotomy.
Objectives: The aim of this study is to evaluate the effect of local bupivacaine which inject at the incision line before surgery in the management of pain after thoracotomy surgery.
Study Design: In a randomized, double-blind clinical trial all patients who candidate for thoracotomy divide into two groups (case and control).
Setting and conduct: Patients enroll in the study after written informed consent, complete history take and all subjects undergo physical examination and preoperative evaluation. All patients receive general anesthesia and surgical procedures are the same for all, intercostals blocks perform at the end of the operation for all patients. A person who inject and nurses do not know about patients' group, so patients receive analgesics as routine and its amount will be recorded. Participants, inclusion and exclusion criteria: All patients who candidate for elective thoracotomy enroll.
Inclusion criteria: Patients age between 10 to 70 years old. Exclusion criteria: drug addictions and chest pain in previous history.
Interventions: In the first group after anesthesia and before thoracotomy incision, 2mg/kg bupivacaine 0.5% diluted by distilled water inject subcutaneously around the site of the incision line, so that infiltrate the entire length of the incision. In control group a placebo (normal saline 0.9%) will inject as same volume and same way which is performing for patients group.
The main outcome variables: The main outcome variables are severity of pain and need to analgesics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052313437N1
Registration date:2014-01-06, 1392/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-06, 1392/10/16
Registrant information
Name
Hamid Reza Hemmati
Name of organization / entity
Semmnan University of Medical Sciecnes
Country
Iran (Islamic Republic of)
Phone
+98 23 1334 0666
Email address
dr.hahemmati@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Semnan University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of local bupivacain injection effect in comparison of placebofor relieving of acute post - thoracotomy pain in patients who undergoing thoracotomy.
Public title
Effect of local bupivacain injection on acute post-thoracotomy pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between10 -70 years old
Exclusion criteria: Drugs abuse; Chest pain in previous history.
Age
From 10 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
91/16/16595
Health conditions studied
1
Description of health condition studied
pain after thoracotomy
ICD-10 code
G89.12
ICD-10 code description
Acute pain after thoracotomy
Primary outcomes
1
Description
pain severity in thoracotomy incision site
Timepoint
2, 4, 8, 24 hours after thoracotomy
Method of measurement
Visual analogue scale (VSA)
Secondary outcomes
1
Description
Need to analgesics
Timepoint
After termination of surgery
Method of measurement
monitoring
Intervention groups
1
Description
The first group after anesthesia and before thoracotomy incision, 2mg/kg bupivacaine 0.5% diluted by distilled water inject subcutaneously around the site of the incision line, so that the entire length of the incision infiltrate.
Category
Treatment - Drugs
2
Description
In control group after anesthesia and before thoracotomy incision a placebo (normal saline 0.9%) will inject subcutaneously around the site of the incision line, so that the entire length of the incision infiltrate.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Farzaneh Husseini
Street address
Imam Hussein square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Raheb Ghorbani
Street address
Basidj Boulevard
City
Semnan
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, Semnan University of Medical Sciences