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

NCT07268495 | Recruiting DMC

• 1 other identifier: Shaoling Ma-2025-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

lidocaine; myomectomy; laparoscopic surgery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• The incidence rate of moderate to severe pain within 24 hours

  Pain severity was measured using The NRS((Numerical Rating Scale),The NRS≥4 was considered moderate to severe pain. If the NRS score is greater than or equal to 4 at least once within 24 hours, it is considered moderate to severe pain.

  Within 24 hours after surgery

Secondary Outcomes (7)

• NRS scores at different time intervals

  2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery

• Sleep quality

  Within 48h hours after surgery

• Recovery quality

  The first two days after surgery

• The consumption of analgesic drugs.

  Within 24 hours after surgery

• The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs.

  During surgery and within 24 hours after surgery

Study Arms (4)

Group C(Control Group)

ACTIVE COMPARATOR

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.

Drug: Saline

Group IV(Intravenous injection of lidocaine Group)

EXPERIMENTAL

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.

Drug: intravenous +saline lidocaine

Group IP(Intraperitoneal spray of lidocaine Group)

EXPERIMENTAL

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.

Drug: saline + intraperitoneal lidocaine

Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)

EXPERIMENTAL

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.

Drug: intravenous + intraperitoneal lidocaine

Interventions

Saline 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.

Also known as: placebo

Group C(Control Group)

saline + intraperitoneal lidocaine 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.

Also known as: intraperitoneal spary of lidocaine

Group IP(Intraperitoneal spray of lidocaine Group)

intravenous + intraperitoneal lidocaine 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.

Also known as: intravenous and intraperitoneal injection of lidocaine

Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)

intravenous +saline lidocaine 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.

Also known as: analgesic

Group IV(Intravenous injection of lidocaine Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Surgery duration exceeding 3 hours;
• Need for additional surgery;
• Allergy to the study drugs;
• Presence of severe psychological,hepatic,renal,and cardiac diseases;
• History of chronic pain or arrhythmia.
• Elimination Criteria:
• The patient or their family withdraws from or refuses to participate in the trial during the observation period;
• Conversion from laparoscopy to laparotomy or change in surgical approach during the procedure.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride; Analgesics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Ma Hanxaing

CONTACT

86-13519591508; mahanxiang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 5, 2025
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 20, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)