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IRCT20161225031559N5 IRCT 2022-02-05 Yazd University of Medical Sciences The effect of pre-operative shoulder analgesia on decrease post-operative pain after rotator cuff repair Preventive effect of sub acromial bupivacaine injection on acute pain after arthroscopic rotator cuff repair surgery 2020-07-05 anticipated 64 Complete https://irct.ir/trial/60273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the blanced block randomization method is used to generate quadruple blocks. After the randomization sequence is prepared by the methodologist and using the sealedenvelope online site, the generated sequence will be provided to a technician. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is determined. Based on the randomly selected envelope, the patient is placed in group (A) preoperative injection or group (B) postoperative injection, Blinding description: evaluators and statistical analysts are unaware. The data are written in code A and B in which the analyst and evaluator do not interfere. N/A Arthroscopic rotator cuff repair. Intervention 1: First intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space space after surgery. Intervention 2: Second intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space one hour after surgery. 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 Amin Adeli Mirzaei
Farokhi Street
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3312 2002 amin_adeli21@yahoo.com Yazd University of Medical Sciences scientific Seyed Houssien Saeed-Banadaky
Farokhi street
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3312 2002 saeed@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Diagnosis of rotator cuff rupture clinically and MRI result. Conscious consent of the participants, Patients who are able to read and write. 30 years 80 years Both Exclusion criteria: Patients with corrective or secondary surgery, patients with a history of trauma in the last 3 months, patients who have other surgeries in addition to rotator cuff repair, Patients who have mental health problems. S46.0 Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Treatment - Drugs Treatment - Drugs First intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space space after surgery. Second intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space one hour after surgery. Post-operative pain score. Timepoint: Pain before and after surgery and up to 3 days after surgery. Method of measurement: Questionnaire, Visual Analogue Scale. Hours of sleep. Timepoint: Pre-operative and post-operative. Method of measurement: questionnaire, The sleep time is entered into the clock in the questionnaire. Yazd University of Medical Sciences Approved 2020-05-11 Ethics committee ofEthics committee of Shahid Sadoughi University of Medical Sciences Bahonar square Yazd Yazd Iran (Islamic Republic of)