Comparison of the effect of prophylactic administration of Quetiapine and Diclofenac sodium on pain relief after major lower limb and pelvic surgeries under spinal anesthesia

The effect of Quetiapine and Diclofenac sodium on pain after major lower limb and pelvic surgeries

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 105 patients. Randomization is done in a simple way by lottery.

This clinical trial will be performed on 105 patients who are candidates for major lower limb and pelvic surgery at Alzahra Hospital in Isfahan. After the approval of the ethics committee and obtaining written consent from the patients, in each group, the patients receive the intervention related to that group 30 minutes before the operation. After entering the operating room, they are fully monitored and after receiving Midazolam and Fentanyl as a premedication, spinal anesthesia is performed by standard methods. After the operation, clinical symptoms and Surgical complications will also be recorded in the patient. The severity of the patient's pain is also measured and recorded according to the VAS criteria. The person who records the patient's symptoms is different from the researcher injecting the drug and is unaware of the type of intervention. The patient is also unaware of the type of intervention and is therefore blind.

All patients aged 18 to 65 years who are candidates for major lower limb and pelvic surgery under spinal anesthesia can enter the study if they do not have a specific underlying disease and do not take drugs that interfere with the study interventions.

Intervention group A: In this group, patients receive 50 mg of oral Quetiapine 30 minutes before surgery. Intervention group B: In this group, patients receive 100 mg of oral Diclofenac sodium 30 minutes before surgery. Intervention group C: In this group, patients receive a placebo 30 minutes before the operation.

The amount of pain after surgery

This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs and placebo are placed in the desired number in sealed opaque and uniform sealed envelopes. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups.

This is a two-blind study, patients are explained that during the study they are placed in one of the groups by lottery, but the type of intervention is not known in advance, so the patient is unaware of the type of intervention despite the conscious participation in the study and is therefore blind. Medications are also prescribed by a researcher who is not involved in evaluating the patient and analyzing the results. An anesthesiologist who is in charge of anesthesia management and data collection during and after surgery, as well as the researcher who evaluates and analyzes the results, will not know the type of drug prescribed and therefore are all blind.