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NCT Number: NCT07268495

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location status: Recruiting

Location contact

Ma Han xiang

CONTACT

[email protected]

86-13519591508

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: placebo

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.

Other names: analgesic

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.

Other names: intraperitoneal spary of lidocaine

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.

Other names: intravenous and intraperitoneal injection of lidocaine

Primary outcomes

  1. The incidence rate of moderate to severe pain within 24 hours

    Time frame: 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.

Secondary outcomes

  1. NRS scores at different time intervals

    Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery

    The severity of pain was measured using the NRS(Numerical Rating Scale), with NRS≥4 indicating moderate to severe pain. The NRS scores for movement, rest, and wound pain at 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery were observed to determine whether intraperitoneal spray combined with intravenous lidocaine could reduce the incidence of moderate to severe pain in patients undergoing laparoscopic myomectomy.

  2. Sleep quality

    Time frame: Within 48h hours after surgery

    The subjective sleep status of Day 0, Day 1 and Day 2 was assessed using the AIS scale. For patients with an AIS score of 4 or higher, the Insomnia Severity Index (ISI) was used to classify the degree of insomnia.

  3. Recovery quality

    Time frame: The first two days after surgery

    The Qor-15 scale was used to evaluate the recovery quality of patients in the first two days. QoR-15 Assessment Questionnaire:It includes five dimensions:physical comfort(5 items),physical independence(2 items),emotional state(4 items),psychological support(2 items),and pain(2 items). Scoring details: Each item is scored on an 11-point scale.Higher scores for positive items indicate higher frequency. The total score ranges from 0(worst recovery)to 150(best recovery).

  4. The consumption of analgesic drugs.

    Time frame: Within 24 hours after surgery

    The consumption of analgesic drugs was recorded, defined as the cumulative consumption of opioids during surgery and the number and type of rescue medications used after surgery.

  5. 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

    The number of adverse reactions to lidocaine in patients during and within 24 hours after surgery was recorded, including tinnitus, perioral numbness, nystagmus, impaired consciousness, muscle twitching, convulsions, coma, bradycardia, arrhythmia, conduction block, hypotension, and circulatory collapse.

    The number and dosage of vasoactive drugs used by patients during surgery were recorded.

    The number of postoperative nausea and vomiting occurrences was recorded, defined as the recording of any nausea or vomiting within 24 hours after surgery.

  6. BIS value

    Time frame: During the operation

    The BIS values of patients before surgery, before skin incision, 30 minutes into the surgery, and at the end of the surgery were recorded.

  7. The time for recovery of bowel function

    Time frame: After surgery

    Record the recovery time of gastrointestinal function,which is defined as the time of the patient's first flatus,first defecation,and removal of the urinary catheter immediately after the surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Ma Hanxaing

CONTACT

[email protected]

86-13519591508

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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