Comparison of the analgesic effects of intra-articular injection of Ropivacaine7.5% with dexmedetomidine and Ropivacaine7.5% with magnesium and Ropivacaine7.5% with ketamine after ACL surgery

Comparison of the analgesic effects of intra-articular injection of rovacaine 7.5% with dexmedetomidine, rovacaine 7.5% with magnesium and rovacaine 7.5% with ketamine after ACL surgery.

Clinical trial without control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients. A table of random numbers will be used for randomization. 60 patients in three groups of 20 are subjected to three types of intervention.

This study prospectively compares the analgesic effects of intra-articular injection of rovacaine 7.5% with dexmedetomidine,rovacaine 7.5% with magnesium and rovacaine 7.5% with ketamine after ACL surgery. At the end of the surgery, drugs are injected intra-articularly and the pain level of the patients will be evaluated at 1, 2, 6, 12 and 24 hours after the operation and will be compared between the three groups. This study is double-blind and patients and evaluators will be unaware of the type of treatment. Also, the data analyst will only have the code of the intervention groups and will not be able to distinguish the treatment groups.

Inclusion criteria: Age between 18 and 60 years, Elective ACL surgery candidate, ASA I and II physical condition Exclusion criteria: Sensitivity to the drugs used in the study, Pregnancy and breastfeeding, Having diabetes, alcohol consumption, Severe liver and kidney failure

1. Ruvacaine 7.5% with dexmedetomidine (100 µg in 10 ml of normal saline) 2. Ruvacaine 7.5% with magnesium (500 mg of 5% magnesium sulfate solution) 3. Ruvacaine 7.5 % together with ketamine (0.5 mg/kg)

The pain level of the patients at 1, 2, 6, 12 and 24 hours after the operation will be evaluated using the Visual Analogue Scale.

The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used. The randomization unit was individual and on this website, after specifying the number of intervention groups, which were three groups, and the required number in each of these groups, the website provided us with a random table of repetitions that represented the patient number. To hide the random allocation, central randomization was used. In this method, a random sequence is placed in the possession of an individual or a specific center, and sampling is done in one or more centers at the same time. Based on the order in which the participants entered the study, the researcher contacted the relevant center and asked about the random assignment of the participants to a special group.

This study was double-blind and the patients and evaluators were unaware of the type of treatment. Also, the study data analyst only had the codes of the treatment groups (1, 2, and 3) and they were not able to distinguish the treatment groups.

All data can be shared after de-identification of individuals and coding of patients, including outcome demographics.

The access period will start after the results are printed.

The data will be available only to researchers working in academic and scientific institutions.

Email and request from the person in charge of the study.

Send a message to the email below. rmoshari@yahoo.com

After the request by email, the person in charge of the study will send the data to the individual.