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Recruiting NCT07268495

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

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline, intravenous +saline lidocaine, saline + intraperitoneal lidocaine, intravenous + intraperitoneal lidocaine.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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.
  • 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.
  • 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.
  • 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.

Primary outcome measures

  • The incidence rate of moderate to severe pain within 24 hours [Time frame: Within 24 hours after surgery]
Secondary outcome measures (7)
  • NRS scores at different time intervals [Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery]
  • Sleep quality [Time frame: Within 48h hours after surgery]
  • Recovery quality [Time frame: The first two days after surgery]
  • The consumption of analgesic drugs. [Time frame: Within 24 hours after surgery]
  • The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs. [Time frame: During surgery and within 24 hours after surgery]
  • BIS value [Time frame: During the operation]
  • The time for recovery of bowel function [Time frame: After surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • General Hospital of Ningxia Medical University — Yinchuan

Identifiers

NCT: NCT07268495 · Shaoling Ma-2025-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗