Objectives
We aimed to determine the impact of subcutaneous injection of 0.5% bupivacaine into the surgical incision on hemodynamic changes during operation in the lower abdominal surgeries.
Design
In a randomized, case-control clinical trial, phase 3, forty-four patients who were candidate for lower abdominal surgery at sensory level below the umbilicus (anesthesia at T10 level) and referred for surgery to Kowsar hospital enrolled in study.
Setting and conduct
Participating patients were randomly assigned to the intervention or control groups by randomization blocks if they fulfilled inclusion criteria, then interventions were done.
Participants including major eligibility criteria
Patients in class I and II based on American Surgery Association (ASA) classification who candidate for lower abdominal surgery at sensory level below the umbilicus (anesthesia at T10 level) including inguinal hernia, varicoceles and appendectomy, enrolled in study. All patients with underlying conditions including heart disease, thyroid disorders, uncontrolled diabetes and age more than 65 years excluded from study.
Intervention
In the case group, bupivacaine was subcutaneously injected into the surgical incision and surgery performed under general anesthesia. In the control group normal saline was subcutaneously injected into the surgical incision as placebo and surgery was done under general anesthesia.
Main outcome measures
Mean arterial blood pressure and heart rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061024625N3
Registration date:2016-11-04, 1395/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-04, 1395/08/14
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-19, 1395/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of subcutaneous injection of 0.5% bupivacaine into skin incision on hemodynamic changes during operation in lower abdominal surgeries.
Public title
Impact of subcutaneous injection of 0.5% bupivacaine into skin incision on hemodynamic changes during operation.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients in class I and II based on American Surgery Association classification candidate for lower abdominal surgery at sensory level below the umbilicus (anesthesia at T10 level).
Exclusion criteria: Underlying heart disease; thyroid disorders; uncontrolled diabetes; age more than 65 years; receiving of calcium channel blockers and beta adrenergic medications; sensitivity to local anesthetics.
Age
To 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was done by randomized blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Amir Kabir Bridge, Basidje Boulevard
City
Semnan
Postal code
3519747167
Approval date
2015-10-06, 1394/07/14
Ethics committee reference number
IR.SEMUMS.REC.1394.90
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
2
Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
3
Description of health condition studied
Varicocele
ICD-10 code
I86.1
ICD-10 code description
Scrotal varices
Primary outcomes
1
Description
Atrial blood pressure
Timepoint
During surgery
Method of measurement
Monitoring
Secondary outcomes
1
Description
Heart Rate
Timepoint
During surgery
Method of measurement
Monitoring
Intervention groups
1
Description
In the first group (intervention), bupivacaine 0.5% , 5 mg/kg was subcutaneously injected at the incision site and surgery performed under general anesthesia.
Category
Treatment - Drugs
2
Description
In the second group (control) surgery was done under general anesthesia after subcutaneous injection of normal saline at similar volume in the incision site as placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital, Educational, research and therapeutic center
Full name of responsible person
Parinaz Mirzaei
Street address
Amin Avenue, Basidje Boulevard
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidje 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 of Semnan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Babak Husseinzadeh
Position
Anesthesiologist/ AssistantProfessor
Other areas of specialty/work
Street address
Amin Avenue, Basidj Boulevard.
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7844
Fax
Email
babakhz.anesthesia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Other areas of specialty/work
Street address
Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)