Comparison of the effectiveness of Pregabalin with Pregabalin-Paracetamol on postoperative pain Lumbar discectomy surgery; A Randomized clinical trial

Comparison of the effect of pregabalin with pregabalin-paracetamol on pain after lumbar discectomy

double-blind randomized clinical trial, phase 3 on 60patients, web-based randomization software was used for randomization.

The present study will be performed in the field of pain relief in 60 patients aged 20-60 years who are candidates for discectomy at Imam Ali Hospital of North Khorasan University of Medical Sciences. Patients are randomly assigned to two groups using a web-based system. Pain assessment will be assessed by visual analog scale pain measuring instruments at time intervals: recovery, 6, 12, 18 and 24 hours after surgery. To perform blinding, patients, surgeons, and individuals performing pain assessments at different intervals will be blinded to the groups.

Inclusion criteria: Age between 20 to 60 years. Physical classification of grades one and two based on the guidelines of the American Anesthesia Association, non-drug addiction. Hypersensitivity to pregabalin and paracetamol. Exclusion criteria: If the patient has heart, vascular and liver problems. If the patient has a history of lumbar surgery.

In the first group, the intervention will be that one hour before the operation, they receive a single dose of pregabalin 300 mg orally and 100 cc of normal 0.9% saline by infusion 30 minutes before the end of the surgery. In the second group, the intervention will be that one hour before the operation, they receive a single dose of pregabalin 300 mg orally and the drug paracetamol 1 g per 100 cc of normal saline 0.9% diluted by infusion 30 minutes before surgery. they receive.

Postoperative pain

Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 4. So that in each block, there are 2 people in the first group (A), two people in the second group (B). After a random sequence was identified in all blocks, cards were written by writing A and B to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 60 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group.

None of the participants in the study will be aware of the randomization list and also to apply allocation concealment randomization, the groups are placed in closed envelopes in the admission section and eligible individuals who enter the study are included respectively. In this study, there is a placebo (normal saline) for paracetamol, patients don't know whether it is paracetamol or a placebo. Also, the clinical caregiver and the person evaluating the outcome are also aware of the interventions, but they don't know about patient's allocation. Thus, the patient, clinical caregiver, evaluator and data analyst are blinded to the study groups.

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