Comparison of preoperative percutaneous electrical nerve stimulation on intensity of pain surgery in patient under inguinal herniorrhaphy in case and control groups
This double-blind randomized clinical trial will be performed with the aim of evaluating the effect of percutaneous electrical nerve stimulation on post operative pain. Patients aged 20 to 50 with physical status of ASA I or II enter the study after obtaining the informed consent. Patients who have the conditions that prohibit the use of TENS device or who chronically use opioids or antidepressants will be excluded from the study. This study will be performed unicentrally on 66 men with inguinal hernia who underwent herniorrhaphy surgery with the Lichtenstein method. The patients are divided into two groups of case and control using the table of random numbers. TENS is performed on the patients one hour before the surgery. In the case group the TENS device is connected to the surgical incision site. In the placebo group the device is connected but there is no electrical stimulation. All the patients are evaluated for baseline pain sensitivity before the operation. In both groups after transition to the ward, analgesia will be established by the use of continuous infusion pump (PCA). The intensity of postoperative pain will be assessed by visual analog scale method at 2, 4, 6, 12 and 24 hours after the surgery. The amount of opioid analgesics, diclofenac and metoclopramide consumption is recorded. The above information along with demographic characteristics of the patients and duration of surgery are recorded in data forms and will be statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102311228N1
Registration date:2013-01-03, 1391/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Monir Janzamini
Name of organization / entity
Kashan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0026
Email address
janzamini@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan university of medical sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preoperative percutaneous electrical nerve stimulation on intensity of pain surgery in patient under inguinal herniorrhaphy in case and control groups
Public title
Effect of preoperative percutaneous electrical nerve stimulation on severity of postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male, aged 20 to 50, suffering from inguinal hernia; Use of Liechtenstein surgical procedure; Surgery performed in the morning to avoid circadian cycle; Physical status of ASA I or II; Absence of hearing, visual or talking impairment; Lack of cognitive impairment; No exclusion criteria
Exclusion criteria: Conditions prohibiting the use of TENS, (such as pacemakers, because of the unknown effects of TENS on electrical conduction system or placing the electrode directly on open wounds); Obesity (weight more than 100 pounds above ideal weight); Recurrent, incarcerated and bilateral hernia; Skin infection or severe skin disease in the place of the electrodes; Chronic use of narcotics or antidepressant drugs
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Kashan University of Medical Sciences ethics committee
Street address
Kashan Medical Sciences complex, Ghotbe Ravandi Blvd., Vice chancellor for research
City
Kashan
Postal code
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
3145/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
The surgical site pain
Timepoint
2, 4, 6, 12 and 24 hours after the surgery
Method of measurement
Using the visual analog scale method
Secondary outcomes
1
Description
Vomitting
Timepoint
2, 4, 6, 12 and 24 hours after the surgery
Method of measurement
Asking the patient
2
Description
Nausea
Timepoint
2, 4, 6, 12 and 24 hours after the surgery
Method of measurement
Asking the patient
Intervention groups
1
Description
In the case group one hour before the surgery TENS device EV-906 model made in Taiwan is connected to the incision site by the interviewer number 1. Sensory intensity is activated in the range of 9 to 18 mA in the TENS device. Frequency and wavelength in each channel is increased until the patient is able to feel tingling without any unpleasant sensation. The prediction of postoperative pain is done by the interviewer number 2 using the Face Scale
Test. In the operating room 2 micrograms per kilogram of fentanyl is prescribed as premedication. Anesthesia is induced with 6 milligrams per kilogram of Nesdonal. During the operation, two micrograms per kilogram per hour fentanyl is prescribed as analgesic. After the surgery the patient will be monitored in the recovery room for 2 hours. During this time, if the patient's pain score based on Face-scale Test is over 4 IV infusion of 25 mg pethidine will be administered. After installation of the PCA pump which contains 200 mg pethedine dissolved in 100 cc normal saline the patient is transferred to the ward. If the button is pressed by the patient the amount of 1 cc of pethidine and normal saline solution is simultaneously injected.
This dose can only be repeated for four times in an hour. If the patient's complaint of pain persists 100 mg diclofenac suppository is used. Questionnaire (containing questions about severity of pain, nausea, vomiting, headache and dizziness, and the amount of analgesic consumption) at 4, 6, 12 and 24 hours after the surgery is completed by asking the patient and evaluation of the PCA pump, and the patient's file.
Category
Treatment - Devices
2
Description
In the control group one hour before the surgery TENS device EV-906 model made in Taiwan is connected to the incision site by the interviewer number 1. The indicator light is on but the device is inactive. The prediction of postoperative pain is done by the interviewer number 2 using the Face Scale Test. In the operating room 2 micrograms per kilogram of fentanyl is prescribed as premedication. Anesthesia is induced with 6 milligrams per kilogram of Nesdonal. During the operation, two micrograms per kilogram per hour fentanyl is prescribed as analgesic. After the surgery the patient will be monitored in the recovery room for 2 hours. During this time, if the patient's pain score based on Face-scale Test is over 4 IV infusion of 25 mg pethidine will be administered. After installation of the PCA pump which contains 200 mg pethedine dissolved in 100 cc normal saline the patient is transferred to the ward. If the button is pressed by the patient the amount of 1 cc of pethidine and normal saline solution is simultaneously injected. This dose can only be repeated for four times in an hour. If the patient's complaint of pain persists 100 mg diclofenac suppository is used. Questionnaire (containing questions about severity of pain, nausea, vomiting, headache and dizziness, and the amount of analgesic consumption) at 4, 6, 12 and 24 hours after the surgery is completed by asking the patient and evaluation of the PCA pump, and the patient's file.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chancellor for research, Pezeshk Blvd., Ghotbe Ravandi Blvd.
City
Kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Monir Janzamini
Position
General Surgery Assistant
Other areas of specialty/work
Street address
General Surgery Group, First Floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
janzamini@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Monir Janzamini
Position
General Surgery Assistant
Other areas of specialty/work
Street address
General Surgery Group, First Floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
janzamini@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Monir Janzamini
Position
General Surgery Assistant
Other areas of specialty/work
Street address
General Surgery Group, First Floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
janzamini@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)