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IRCT20220107053657N1 IRCT 2022-02-22 Tehran University of Medical Sciences Evaluation of vibration in pain in spinal anesthesia Evaluation of the effect of vibration in reducing pain and movement of the patient during spinal anesthesia 2022-02-01 anticipated 68 Complete https://irct.ir/trial/61187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The list of random allocation of patients will be available only to the epidemiologist of the project. To hide the random allocation process, the corresponding treatment type will be written on 68 cardboard and will be placed in a paper envelope. Only the design methodologist will be aware of the contents of the envelopes. The cards will be arranged in a randomized list inside the box. Random allocation software is also used for randomization tools. In addition to simple randomization, these random sequence generation software is able to generate random sequences. When the physician declares a patient eligible, the methodologist will provide the therapist with an envelope design. The person assessing the intended outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. To analyze the data, a statistician who is separate from the study process and is unaware of all the processes performed will be used, Blinding description: The patient takes the drug (intervention or comparison group) in sealed envelopes that code Have been received. Coded by one of the design partners And the doctor and the evaluator and the patient are blind. N/A Condition 1: spinal anesthesia. Condition 2: spinal anesthesia. Intervention 1: Intervention group: vibration on location of spinal anesthesia. To perform spinal anesthesia, we sit the patient and in the middle line in the space between the vertebrae L4 and L5, we sterilize the area where the needle enters and we put the vibrator device in the sterile cover and we put it for 30 seconds to 1 minute and then a little We move and finally continue the vibration at the entrance of the needle and under the supervision of a doctor under constant anesthesia, insert the needle during the study process and then remove the mandrel and after removing the CSF fluid (cerebrospinal fluid) local anesthetic We prescribe 0.5% bupivacaine depending on the surgical site between 10-15 mg and then remove the needle and bandage the site and put the patient to sleep in supine position. Intervention 2: Control group: Spinal anesthesia was performed without vibrator. To perform spinal anesthesia, we sit the patient and sterilize the area where the needle is inserted in the middle line in the space between L4 and L5 vertebrae. When CSF (cerebrospinal fluid) is removed, we prescribe a local anesthetic, bupivacaine 0.5%, depending on the surgical site, between 15 and 15 mg, and then remove the needle, bandage the area, and put the patient to sleep in a supine position. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Nader Ali Nazemian Yazdi
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
Tehran Iran (Islamic Republic of) 6511111457 +98 21 6634 3352 shaqayeqrefahi6@gmail.com Tehran University of Medical Sciences scientific Nader Ali Nazemian Yazdi
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
Tehran Iran (Islamic Republic of) 6511111457 +98 21 6634 3352 shaqayeqrefahi6@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for abdominal surgery including herniorrhage, mesh implantation section ,gastrostomy and jejunostomy Age group 20 to 70 years They are also ASA 1-3 20 years 70 years Both Spinal anesthesia should be abolished and we should have to anesthetize the patient with general anesthesia for surgery, and our anesthesia should not be sufficient for surgery. The anesthesia is incomplete and we have to use drugs or ketamine to continue the surgery. O74.5 O74.6 Spinal and epidural anesthesia-induced headache during labor and delivery Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Devices Treatment - Devices Intervention group: vibration on location of spinal anesthesia. To perform spinal anesthesia, we sit the patient and in the middle line in the space between the vertebrae L4 and L5, we sterilize the area where the needle enters and we put the vibrator device in the sterile cover and we put it for 30 seconds to 1 minute and then a little We move and finally continue the vibration at the entrance of the needle and under the supervision of a doctor under constant anesthesia, insert the needle during the study process and then remove the mandrel and after removing the CSF fluid (cerebrospinal fluid) local anesthetic We prescribe 0.5% bupivacaine depending on the surgical site between 10-15 mg and then remove the needle and bandage the site and put the patient to sleep in supine position. Control group: Spinal anesthesia was performed without vibrator. To perform spinal anesthesia, we sit the patient and sterilize the area where the needle is inserted in the middle line in the space between L4 and L5 vertebrae. When CSF (cerebrospinal fluid) is removed, we prescribe a local anesthetic, bupivacaine 0.5%, depending on the surgical site, between 15 and 15 mg, and then remove the needle, bandage the area, and put the patient to sleep in a supine position. Pain. Timepoint: after intervention, one week, one month after intervention. Method of measurement: Visual Analogue Scale. Tehran University of Medical Sciences Approved 2021-05-15 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Tehran Province, Tehran, Pour Sina St, Iran Tehran Tehran Iran (Islamic Republic of)