Objective: The goal of this study was to compare the analgesic effects of lidocaine versus ketamine wound infiltration on postoperative pain in inguinal herniorrhaphy.
Patients and Methods: A total of 69 American Society of Anesthesiologist (ASA) class I-II patients, aged between 20 and 60 years old, scheduled for elective unilateral inguinal herniorrhaphy were enrolled in this double-blinded, clinical trial study. They were randomly divided into 3 equal groups (by using the colored cards). Patients in the three groups was operated under general anesthesia. Drugs were used for premedication, induction and maintenance of anesthesia were the same in the three groups. In the first group lidocaine1% (1mg/kg) and in the second group ketamine (0.5mg/kg) was infiltrated at the incisional site. Patients in the third group (control) did not receive any drug for wound infiltration. For comparison of postoperative pain, Visual Analogue Scale (VAS) was evaluated after the first hour of recovery period when the patients were alert and cooperative .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204087695N2
Registration date:2012-04-18, 1391/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Seyedeh Masoumeh Hosseini Valami
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 8419
Email address
smhosseiniv@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2010-07-11, 1389/04/20
Expected recruitment end date
2010-12-30, 1389/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Lidocaine Versus Ketamine Wound Infiltration on Postoperative Pain in Inguinal Herniorrhaphy
Public title
Comparison the Effects of Lidocaine Versus Ketamine Wound Infiltration on Postoperative Pain in Inguinal Herniorrhaphy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 60 years old; ASA I,II and unilateral inguinal herniorrhaphy.
Exclusion criteria: positive history of anti-convulsive, opioids, analgesic, sedative, corticosteroid and non steroidal anti-inflammatory drugs consumptions; patients with elevated intracranial pressure; positive history of coronary artery disease, psychiatric disorder, convulsion and positive history of allergic reaction to lidocaine.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Qazvin university of medical sciences
Street address
Shahid Bahonar Street ,Qazvin university of medical sciences
City
Qazvin
Postal code
Approval date
2010-07-06, 1389/04/15
Ethics committee reference number
4402/20/د
Health conditions studied
1
Description of health condition studied
Diseases of the digestive system
ICD-10 code
K40.3
ICD-10 code description
Unilateral or unspecified inguinal hernia, with obstruction, without gangrene
Primary outcomes
1
Description
Pain
Timepoint
One hour after arriving the patients to recovery room
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Systolic and diastolic blood pressure and heart rate
Timepoint
Each 5 minutes during the first one hour of recovery period
Method of measurement
By monitoring of vital sign
Intervention groups
1
Description
In the first group lidocaine1% (1mg/kg) was infiltrated at the incisional site.
Category
Treatment - Drugs
2
Description
In the second group ketamine (0.5mg/kg) was infiltrated at the incisional site.
Category
Treatment - Drugs
3
Description
Patients in the third group (control) did not receive any drug for wound infiltration.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaee Hospital
Full name of responsible person
Seyedeh masoumeh Hosseini Valami
Street address
Shaheed Rajaee Hospital, Padegan street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research ,Qazvin university of medical sciences
Full name of responsible person
Dr Saeid Asefzadeh
Street address
Shahid Bahonar street ,Qazvin university of medical sciences
City
Qazvin
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 ,Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh hosseini Valami
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar Street
City
Qazvin
Postal code
Phone
+98 281336001
Fax
+98 28 1334 4812
Email
smhosseiniv@qums.ac.ir / parspaya872008@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar street
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
+98 28 1334 4812
Email
sahosseinij@qums.ac.ir / papaya812002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh hosseini Valami
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar street
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
+98 28 1334 4812
Email
smhosseiniv@qums.ac.ir / parspaya872008@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)