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IRCT20211011052726N2 IRCT 2023-06-06 Mazandaran University of Medical Sciences A Comparison effect of ultrasound bilateral TAP-Block, before start and after the end of surgery, on pain relief in patients underwent laparoscopic cholecystectomy surgery A Comparison effect of ultrasound bilateral TAP-Block, before start and after the end of surgery, on pain relief in patients underwent laparoscopic cholecystectomy surgery 2023-06-10 anticipated 60 Complete https://irct.ir/trial/70318 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation by the method of variable blocks. In this study, the randomization method will be used to generate a random sequence using the block method and the Random allocation software. First, the informed consent form is registered by the patient in writing, and then the participants will be randomly assigned to each group, Blinding description: In this design, blinding is by random double-blind method. In this way, the person evaluating the patient and the patient himself do not know about the groups to which the patient has been assigned. SNOSE method will be used to hide random allocation. This method is one of the common methods in hiding random allocation. In this method, first a random sequence is created using the mentioned software, then based on the sample size of a number of envelopes with aluminum wrappers (in order to make the content of the envelopes unclear), prepare and each of the random sequences created on It is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of starting the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. 2 general anesthesia. Intervention 1: Intervention group:The recipient of TAP-Block is inserted into the plane with an ultrasound guide of the needle (disposable spinal needle 90 mm, 22 gauge) before the surgery (Pre-Surgery) and after placing the tip of the needle in the fascia between the transversus abdominis and internal oblique muscles, 17 mg bupivacaine 0.25% + 1 µg/Kg dexmedetomidine diluted in 3 ml saline 0.9% in a total volume of 20 ml will receive bilaterally. Bupivacaine, Aburihan, Iran, Dexmedetomidine, Elixir, Iran. Intervention 2: Intervention group: The group receiving TAP-Block after surgery (Post-Surgery) and before extubation with an ultrasound guide needle (disposable spinal needle 90 mm, 22 gauge) was inserted into the plane and after placing the tip of the needle in the fascia between the transversus abdominis muscles. and internal oblique, 17 mg bupivacaine 0.25% + 1 µg/Kg dexmedetomidine diluted in 3 ml saline 0.9% in a total volume of 20 ml will receive bilaterally. Bupivacaine, Aburihan, Iran, Dexmedetomidine, Elixir, Iran. 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 "No more information"
public Nafiseh Faghani Makrani
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 dr.nfaghani@gmail.com Mazandaran University of Medical Sciences scientific Nafiseh Faghani Makrani
Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 dr.nfaghani@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 20 to 60 years Physical status according to ASA, I to II Consent to participate in the study Elective cholecystectomy No history of opioid use or tolerance to opioids or alcohol Absence of coagulopathy No history of bupivacaine allergy BMI less than 35 No neurological disease Musculoskeletal such as myelopathy and myasthenia gravis Absence of sleep apnea or any other sleep disorder Absence of any uncompensated systemic diseases such as cardiovascular diseases Respiratory, metabolic, neurological and endocrinological No history of psychiatric problems Not taking psychiatric drugs 20 years 60 years Both Conversion of laparoscopic cholecystectomy to open cholecystectomy Uncontrolled bleeding during surgery T88.59XA Other complications of anesthesia, initial encounter Treatment - Drugs Treatment - Drugs Intervention group:The recipient of TAP-Block is inserted into the plane with an ultrasound guide of the needle (disposable spinal needle 90 mm, 22 gauge) before the surgery (Pre-Surgery) and after placing the tip of the needle in the fascia between the transversus abdominis and internal oblique muscles, 17 mg bupivacaine 0.25% + 1 µg/Kg dexmedetomidine diluted in 3 ml saline 0.9% in a total volume of 20 ml will receive bilaterally. Bupivacaine, Aburihan, Iran, Dexmedetomidine, Elixir, Iran Intervention group: The group receiving TAP-Block after surgery (Post-Surgery) and before extubation with an ultrasound guide needle (disposable spinal needle 90 mm, 22 gauge) was inserted into the plane and after placing the tip of the needle in the fascia between the transversus abdominis muscles. and internal oblique, 17 mg bupivacaine 0.25% + 1 µg/Kg dexmedetomidine diluted in 3 ml saline 0.9% in a total volume of 20 ml will receive bilaterally. Bupivacaine, Aburihan, Iran, Dexmedetomidine, Elixir, Iran Intensity of pain. Timepoint: در ساعت های صفر ، 2، 4، 6، 12 و 24. Method of measurement: The pain intensity of the patients was evaluated based on a visual analogue scale/ it will be evaluated from 0 as no pain to 10 as the most severe pain that the patient has ever experienced. Nausea and vomiting. Timepoint: (zero hour), 2, 4, 6, 8, 12 and 24 hours later. Method of measurement: Nausea and vomiting will be recorded using the following scale at 0 to 2 hours and 2 to 24 hours after surgery. The score will be zero in patients who do not have nausea and vomiting. Score 1 in patients with nausea but no vomiting, score 2 in patients who have nausea and vomiting, and score 3 in patients who have more than two bouts of vomiting within 30 minutes. Mazandaran University of Medical Sciences Approved 2023-04-19 Research Ethics Committee of Mazandaran University of Medical Sciences, Imam Hospital, Sari Amir Mazandarani Blvd. Imam Khomeini Educational and Medical Center Sari Mazandaran Iran (Islamic Republic of)