Comparing the efficacy of Pregabalin with Duloxetine in perioperative pain management in knee fractures surgery: A randomized, double-blind, clinical trial

comparing the effectiveness and effect on reducing opioid consumption and between Pregabalin and Duloxetine as part of a multi-modal analgesia regimen to manage pain orthopedic surgery

Clinical trial, two parallel intervention groups, double-blind, randomized, phase 2 on 68 patients. Block randomization method is used.

Patients who are admitted to Sina Hospital following fractures around the knee and placed on the operation list for surgery, after obtaining informed consent from them or their legal guardians, will be included. with block randomisation method, patients will be divided into two groups and they receive eather capsules containing 75 mg Pregabalin or 30 mg Duloxetine every 12 hours at least 24 hours before surgery until 48h after it. Along with each of these drugs, all patients will similarly receive other analgesics according to hospital protocol. The intensity of the patient's pain at the beginning of the study, immediately before surgary and 6, 12, 24 and 48 hours after it will be evaluated and recorded using a numeric rating scale from 0 to 10. In case of pain intensity greater than 6, intramuscular Morphine will be administered at a dose of 0.05 mg/kg (maximum 4 mg) with a maximum frequency of every 4 hours. The patient will be followed up within 48 hours after the surgery for cumulative opioid consumption and side effects related to the drugs.

Inclusion: age 18 to 80 years /Exclusion: History of taking or allergy to study drugs, dependence to opioid or use within 24 hours before entering the study, Use of epidural anesthesia in surgery

One group will receive an oral capsule containing Pregabalin and another will receive an oral capsule containing Duloxetine (all capsules looks similar).

pain intensity score; Cumulative dose of opioid consumption

Simple block randomization: Patients will be divided into two groups by block randomization of 4 and 6 numbers. The random sequence will be created using the site https://www.sealedenvelope.com/simple-randomiser/v1/li. Concealment will also be done using The block randomization method is guaranteed. Packs of 8 capsules containing Duloxetine and Pregabalin, which are completely similar, are coded and provided to the researcher by a person who is not involved in the treatment, patient monitoring and analysis given in the study. The codes will be kept with this person until the end of the study.

We will have two types of capsules A and B that are completely similar in terms of appearance, which are coded and prepared by someone other than the researchers and the patient, and he knows which type of capsule contains which of the study drugs, and the researcher who interviews the patients and the patients do not know which one Pregabalin or Duloxetine is prescribed for each patient.