The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy

General Hospital of Ningxia Medical University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Drug: saline + intraperitoneal lidocaine; Drug: intravenous + intraperitoneal lidocaine; Drug: intravenous +saline lidocaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07268495

Shaoling Ma-2025-05

Details and patient eligibility

About

The purpose of this study is to determine whether laparoscopic spraying combined with intravenous injection of lidocaine can improve pain in patients undergoing laparoscopic myomectomy under general anesthesia.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age:18-65 years old;
2. ASA physical status classification I - III;
3. Undergoing laparoscopic hysteromyoma resection under general anesthesia;
4. The patient has been informed and has signed the informed consent form.

Exclusion criteria

1. Surgery duration exceeding 3 hours;
2. Need for additional surgery;
3. Allergy to the study drugs;
4. Presence of severe psychological,hepatic,renal,and cardiac diseases;
5. History of chronic pain or arrhythmia.

Elimination Criteria:

1. The patient or their family withdraws from or refuses to participate in the trial during the observation period;
2. Conversion from laparoscopy to laparotomy or change in surgical approach during the procedure.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Group C(Control Group)

Active Comparator group

Description:

At the beginning of the operation, intravenous infusion of reifentanil 0.1\~0.2μg/kg/min, propofol 2\~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%\~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50\~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.

Treatment:

Drug: Saline

Group IV(Intravenous injection of lidocaine Group)

Experimental group

Description:

At the beginning of the operation, intravenous infusion of reifentanil 0.1\~0.2μg/kg/min, propofol 2\~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%\~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50\~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous 2% lidocaine (2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.

Treatment:

Drug: intravenous +saline lidocaine

Group IP(Intraperitoneal spray of lidocaine Group)

Experimental group

Description:

At the beginning of the operation, intravenous infusion of reifentanil 0.1\~0.2μg/kg/min, propofol 2\~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%\~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50\~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.

Treatment:

Drug: saline + intraperitoneal lidocaine

Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)

Experimental group

Description:

At the beginning of the operation, intravenous infusion of reifentanil 0.1\~0.2μg/kg/min, propofol 2\~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%\~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50\~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous infusion 2% lidocaine ( 2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.

Treatment:

Drug: intravenous + intraperitoneal lidocaine