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

NCT ID: NCT07268495

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-20

Brief Summary

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group C(Control Group)

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.

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline 2mg/kg/h was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.

Group IV(Intravenous injection of lidocaine Group)

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.

Group Type: EXPERIMENTAL

intravenous +saline lidocaine

Intervention Type: DRUG

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, 20ml normal saline was administered.

Group IP(Intraperitoneal spray of lidocaine Group)

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.

Group Type: EXPERIMENTAL

saline + intraperitoneal lidocaine

Intervention Type: DRUG

10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline ( 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.

Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)

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.

Group Type: EXPERIMENTAL

intravenous + intraperitoneal lidocaine

Intervention Type: DRUG

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.

Interventions

Saline

10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline 2mg/kg/h was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.

Intervention Type: DRUG

intravenous +saline lidocaine

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, 20ml normal saline was administered.

Intervention Type: DRUG

saline + intraperitoneal lidocaine

10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline ( 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.

Intervention Type: DRUG

intravenous + intraperitoneal lidocaine

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.

Intervention Type: DRUG

Other Intervention Names

placebo; analgesic; intraperitoneal spary of lidocaine; intravenous and intraperitoneal injection of lidocaine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Hanxaing

Role: CONTACT

mahanxiang@hotmail.com

86-13519591508

Facility Contacts

Ma Han xiang

Role: primary

mahanxiang@hotmail.com

86-13519591508

Other Identifiers

Shaoling Ma-2025-05

Identifier Type: -

Identifier Source: org_study_id