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IRCT20220731055587N1 IRCT 2022-07-31 Mashhad University of Medical Sciences The effectiveness of bupivacaine on pain relief after unilateral knee arthroplasty A clinical trial to compare the effectiveness of 0.5% bupivacaine with 0.25% bupivacaine on adductor canal block after unilateral knee arthroplasty 2022-08-23 anticipated 48 Complete https://irct.ir/trial/65031 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of block randomization. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: Patients candidate for unilateral knee arthroplasty referring to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the 0.5% bupivacaine and control will receive 0.25% bupivacaine after surgery. The responsible for data collection is blind to group allocation and the type of intervention. 2-3 Unilateral knee arthroplasty. Intervention 1: Intervention group: The intervention group will receive 0.25% bupivacaine to adductor canal block after unilateral knee arthroplasty. Intervention 2: Control group: The control group will receive 0.5% bupivacaine to adductor canal block after unilateral knee arthroplasty. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Hosnieh Esmaeili Namghi provides the data analysis to the applicants via email: hosnie.esmaili@gmail.com. How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Hosnieh Esmaeili Namghi
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 hosnie.esmaili@gmail.com Mashhad University of Medical Sciences scientific Hosnieh Esmaeili Namghi
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 hosnie.esmaili@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with ASA I or II, who are candidate for unilateral knee arthroplasty Age over 18 years BMI less than 35 18 months no limit Both History of neuropathy Having coagulation disorder Drug abuse Having local anesthetics allergies T84.9XXA Unspecified complication of internal orthopedic prosthetic device, implant and graft, initial encounter Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 0.25% bupivacaine to adductor canal block after unilateral knee arthroplasty. Control group: The control group will receive 0.5% bupivacaine to adductor canal block after unilateral knee arthroplasty. The rate of pain. Timepoint: 3, 6, 12 and 24 hours after intervention. Method of measurement: Visual analogue scale (VAS). Muscle strength. Timepoint: 12 and 24 hours after intervention. Method of measurement: Maximum voluntary isometric contraction (MVIC). The rate of pain reliever consumption. Timepoint: 24 hours after intervention. Method of measurement: Type and amount of pain reliever consumed by the patient. Mashhad University of Medical Sciences Approved 2021-11-06 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)