Objectives:
Determine the effect of topical Bupivacain on pain in patients undergoing craniotomy with intravenouse morphin
Design: Interventional, Double blinded, Patient and investigators have been unaware.
Major Inclusion criteria: More than 18 years of age; Undergoing elective supratentorial craniotomy surgery under general anaesthesia due to tumors or vascular lesions.
Major exclusion criteria: Coronary artery disease with a contraindication to epinephrine administration; Pain due to intracranial pathology, not differentiated from post-operative pain; Addiction to alcohol and drugs; Active psychiatric illness; Chronic pain after more than 2 weeks drug use; Positive history of migraine headaches; Patient’s inability to understand or answer numeric response questions; Confirmed or potential sensitivity to topical anaesthesia; probable need for post-operative mechanical ventilation; Previous craniotomy or history of radiotherapy of the head; Pregnancy.
Intervention group: Bupivacaine 0.25% maximum dose of 2 mg per kilogram of patient weight
Control group: Morphine 0.1 mg per kg of body weight
Primary outcome measure: Patient's pain after surgery, 2, 4, 6, 8, 12 and 24 hours after surgery by Pain Scale Visual
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012513307N2
Registration date:2014-02-20, 1392/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Fariba Hushmandi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 5779
Email address
houshmandif881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2012-03-04, 1390/12/14
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Scalp Infiltration with Bupivacaine Compared with
Intravenous Morphine on the postoperative pain of patients undergoing craniotomy
Public title
Determine the effect of topical Bupivacaine on pain of patients undergoing craniotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Major Inclusion criteria: More than 18 years of age; Undergoing elective supratentorial craniotomy surgery under general anaesthesia due to tumors or vascular lesions.
Major exclusion criteria: Coronary artery disease with a contraindication to epinephrine administration; Pain due to intracranial pathology, not differentiated from post-operative pain; Addiction to alcohol and drugs; Active psychiatric illness; Chronic pain after more than 2 weeks drug use; Positive history of migraine headaches; Patient’s inability to understand or answer numeric response questions; Confirmed or potential sensitivity to topical anaesthesia; probable need for post-operative mechanical ventilation; Previous craniotomy or history of radiotherapy of the head; Pregnancy.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
91375-345
Approval date
2012-03-03, 1390/12/13
Ethics committee reference number
2083226
Health conditions studied
1
Description of health condition studied
Pain after surgery
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Patient's pain after surgery
Timepoint
2, 4, 6, 8, 12 and 24 hours after surgery
Method of measurement
Pain Scale Visual
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bupivacaine 0.25% maximum dose of 2 mg per kilogram of patient weight
Category
Prevention
2
Description
Control group: Morphine 0.1 mg per kg of body weight
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Fariba Houshmandi
Street address
Ghaem Hospital, Ahmadabbad Avenue, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Faribe Houshmandi
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
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 Mashhad 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
Ghaem Hospital
Full name of responsible person
Fariba Houshmandi
Position
Student
Other areas of specialty/work
Street address
Neurology Department, Ghaem Hospital, Ahmad Abad Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1846 5779
Fax
Email
houshmandif881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Hossein Mashhadi Nazar
Position
Associate Professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1840 2205
Fax
Email
mashhadinejadh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Fariba Houshmandi
Position
Student
Other areas of specialty/work
Street address
Neurology Department, Ghaem Hospital, Ahmad Abad Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1846 5779
Fax
Email
houshmandif881@mums.ac.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)