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IRCT2012102311228N1 IRCT 2013-01-03 Vice Chancellor for research, Kashan University of Medical Sciences Effect of preoperative percutaneous electrical nerve stimulation on severity of postoperative pain Comparison of preoperative percutaneous electrical nerve stimulation on intensity of pain surgery in patient under inguinal herniorrhaphy in case and control groups 2012-11-21 anticipated 66 Complete https://irct.ir/trial/11526 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Pain. Intervention 1: 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. Intervention 2: 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.
public Dr. Monir Janzamini
General Surgery Group, First Floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
Kashan Iran (Islamic Republic of) +98 36 1555 0026 janzamini@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Monir Janzamini
General Surgery Group, First Floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
Kashan Iran (Islamic Republic of) +98 36 1555 0026 janzamini@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 50 years Male R10.3 Pain localized to other parts of lower abdomen Treatment - Devices Placebo 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. 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. The surgical site pain. Timepoint: 2, 4, 6, 12 and 24 hours after the surgery. Method of measurement: Using the visual analog scale method. Vomitting. Timepoint: 2, 4, 6, 12 and 24 hours after the surgery. Method of measurement: Asking the patient. Nausea. Timepoint: 2, 4, 6, 12 and 24 hours after the surgery. Method of measurement: Asking the patient. Vice Chancellor for research, Kashan University of Medical Sciences Approved 2012-11-20 Kashan University of Medical Sciences ethics committee Kashan Medical Sciences complex, Ghotbe Ravandi Blvd., Vice chancellor for research Kashan Iran (Islamic Republic of)