The effect of bupivacaine (Marcaine) intraperitoneal instillation on pain reduction after open hysterectomy surgery.

Determination of the effect of bupivacaine intraperitoneal instillation on pain reduction after hysterectomy surgery

A randomized, triple-blinding clinical trial, with parallel groups, Phase 3 on 110patients

In this three-blind randomized clinical trial study, 110 eligible patients, referred to Al-Zahra and Beheshti hospitals in Isfahan, will be included in the study and will be randomly divided into two groups. After surgery, before closing the peritoneum, 40 ml of bupivacaine 0.25% in the first group and 40 ml of normal saline in the second group will be sprayed into the peritoneal cavity. The intervention will be performed in such a way that the patient, the researcher and the statistical analyst will not have any knowledge of the type of intervention. Then the severity of pain and hemodynamic parameters of the patients will be compared between the two groups.

The inclusion criteria include women who are candidates for hysterectomy surgery, in the age range of 18 to 65 years, with ASA class one and two, no history of allergy to the drugs used (bupivacaine or morphine), no underlying disease (such as asthma, other chronic diseases) and consent to participate in the study. The exclusion criteria is drug use (having an addiction).

Intervention group: In this group, 40 ml of bupivacaine 0.25% is sprayed into the peritoneal cavity. Control group: In this group, 40 ml of normal saline will be sprayed into the peritoneal cavity.

Systolic blood pressure, diastolic blood pressure, heart rate, oxygen saturation(Spo2); Severity of pain

Before starting the study, letter A is written on 55 sheets, letter B is written on 55 sheets, and each is placed in an envelope. Then, each eligible patient who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the two groups according to the envelope selected without the interference of the researcher.

In order to comply with the condition of triple-blindness of the study, two drugs, bupivacaine and normal saline, will be prepared by the operating room nurse (without the knowledge of the researcher) in equal volumes (40 mg) in syringes covered with labels A, B and will be prepared and placed in the bag daily. And it is given to the researcher daily. Therefore, the researcher, the patient, the person recording the clinical and basic information of the patients, as well as the statistical analyst, will not be aware of the type of intervention.

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