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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Saline; Drug: intravenous +saline lidocaine; Drug: saline + intraperitoneal lidocaine; Drug: intravenous + intraperitoneal lidocaine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ma Hanxaing; Phone Number: 86-13519591508; Email: mahanxiang@hotmail.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Ma Han xiang; Phone Number: 86-13519591508; Email: mahanxiang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: placebo
Experimental: 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.	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.; Other Names: analgesic
Experimental: 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.	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.; Other Names: intraperitoneal spary of lidocaine
Experimental: 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.	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.; Other Names: intravenous and intraperitoneal injection of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS scores at different time intervals	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 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
Sleep quality	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.	Within 48h hours after surgery
Recovery quality	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).	The first two days after surgery
The consumption of analgesic drugs.	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.	Within 24 hours after surgery
The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs.	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.	During surgery and within 24 hours after surgery
BIS value	The BIS values of patients before surgery, before skin incision, 30 minutes into the surgery, and at the end of the surgery were recorded.	During the operation
The time for recovery of bowel function	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.	After surgery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: lidocaine; laparoscopic surgery; postoperative pain; myomectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Inorganic Chemicals; Chlorine Compounds; Central Nervous System Agents; Sodium Compounds; Chlorides; Hydrochloric Acid; Analgesics; Sodium Chloride
• Other Study ID Numbers: Shaoling Ma-2025-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No