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IRCT20141209020258N127 IRCT 2019-12-26 Arak University of Medical Sciences An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement An investigation into the analgesic effects of Apotel and transcutaneous electrical nerve stimulation on post-operative pain management of patients with knee replacement 2018-10-07 anticipated 88 Complete https://irct.ir/trial/44156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B.‏ In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. 3 Knee joint replacement. Intervention 1: Intervention group: In the TENS group, 4 pads are placed on each side of the waist around L1 to T10 for half an hour 1, 6, and 12 hours after surgery. Pad sizes are 40 x 100.To study the frequency of the device is set to 100 Hz. The device is for Body Clock Health Care London.With an output of 0 to 110 mA, which is represented by Tasmanim Arman Behbod Company in Iran. Intervention 2: Control group: In the Apotel group, one gram in 10 ml of normal saline was given in recovery and continued for 24 hours postoperatively. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Alireza Kamali How to obtain: They have to write letters to the professors and the university Comments:
public Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) People aged 20 to 80 with normal preoperative mobility 20 years 80 years Both Patients with neuropathic pain or sensory impairment in the case of surgery History of previous knee surgery Sensitivity to medications Body mass index more than 40 No underlying disease M23.9 Internal derangement of knee, unspecified Treatment - Devices Treatment - Devices Intervention group: In the TENS group, 4 pads are placed on each side of the waist around L1 to T10 for half an hour 1, 6, and 12 hours after surgery. Pad sizes are 40 x 100.To study the frequency of the device is set to 100 Hz. The device is for Body Clock Health Care London.With an output of 0 to 110 mA, which is represented by Tasmanim Arman Behbod Company in Iran. Control group: In the Apotel group, one gram in 10 ml of normal saline was given in recovery and continued for 24 hours postoperatively. Pain. Timepoint: At recovery time, 2, 4, 8, 12 and 24 hours after surgery. Method of measurement: Visual analogue pain questionnaire. Amount of narcotic drug used. Timepoint: During 24 hours after surgery. Method of measurement: milligram. Mean arterial blood pressure. Timepoint: First and in recovery. Method of measurement: Barometer. Mean heart rate. Timepoint: First and in recovery. Method of measurement: Count. Oxygen saturation percentage. Timepoint: First and in recovery. Method of measurement: Pulse Oximeter. Arak University of Medical Sciences Approved 2018-09-23 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)