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Clinical Trials in China / NCT07268495
Recruiting Not applicable

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

NCT07268495 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Ningxia Medical University
Phase
Not applicable
Started
2024-08-01
Last updated
2025-12-05

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

Salineintravenous +saline lidocainesaline + intraperitoneal lidocaineintravenous + intraperitoneal lidocaine

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.

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.

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The incidence rate of moderate to severe pain within 24 hours — Within 24 hours after surgery
    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.

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Ningxia Medical University Yinchuan Ningxia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07268495 on ClinicalTrials.gov ↗ ← All trials in China