Comparing the preventive effect of infiltration into the surgical incision "bupivacaine" with "bupivacaine plus dexmedetomidine" in reducing pain after caesarean section.

Determining and comparing the preventive effect of infiltration into the surgical incision "bupivacaine" with "bupivacaine plus dexmedetomidine" in reducing pain after caesarean section.

A randomized, double-blinding clinical trial, with parallel groups, Phase 2 on 80 patients

In this randomized double-blind clinical trial study, 80 eligible patients referred to Beheshti and Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into two groups. In the first and second groups, respectively, "bupivacaine" and "bupivacaine plus dexmedetomidine" were prescribed as local subcutaneous wound infiltration. Then the pain intensity, hemodynamic parameters, and complications of the patients will be evaluated and compared between the two groups.

The inclusion criteria of the study include patients who are candidates for cesarean surgery of the elective type, the maximum duration of the operation is 90 minutes, the cesarean surgery is performed under spinal anesthesia or anesthesia from the back, and consent to participate in the study. Exclusion criteria include having an uncontrollable underlying disease, twin pregnancy and higher, having a history of allergies to the drugs used and the lack of opioids' effect on them, and having acute or chronic pain before surgery.

First intervention group: In this group, local subcutaneous wound infiltration of 0.25% bupivacaine (3 mg/kg) diluted with normal saline up to 40 ml will be done. Second intervention group: In this group, local subcutaneous wound infiltration of 0.25% bupivacaine (3 mg/kg) plus dexmedetomidine (1.5 μg/kg) of body weight diluted with normal saline up to 40 ml will be done.

Pain; Blood pressure; Percentage of oxygen saturation (SPO2); Heart rate; Complications

In this study, 80 eligible patients are randomly selected. Then the letters A and B are written on 400 sheets and each one is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.

In order to achieve the double-blind study, two drugs, bupivacaine and the combination of bupivacaine and dexmedetomidine, will be prepared and placed in the bag daily before surgery (without the knowledge of the researcher) and will be labeled A, B. And is given daily to the anesthesiologist (researcher). Therefore, the patient, care provider, investigator, outcome assessor, and data analyzer will not be aware of the type of intervention.

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