Intraperitoneal spray plus IV lidocaine to reduce pain after laparoscopic myomectomy
The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy
This will test whether using a lidocaine spray inside the abdomen plus IV lidocaine reduces pain after laparoscopic myomectomy in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | General Hospital of Ningxia Medical University Academic / other |
| Locations | 1 site (Yinchuan, Ningxia) |
| Trial ID | NCT07268495 on ClinicalTrials.gov |
What this trial studies
Adults undergoing laparoscopic myomectomy under general anesthesia are assigned to one of four intraoperative treatments combining intravenous and intraperitoneal lidocaine or saline. Pain after surgery will be compared between the groups to see if the combined route lowers postoperative pain. Eligible participants are aged 18–65 with ASA I–III and provide informed consent, while those with long surgeries or certain comorbidities are excluded. The trial is conducted at the General Hospital of Ningxia Medical University in Yinchuan.
Who should consider this trial
Good fit: Adults 18–65 with ASA physical status I–III scheduled for laparoscopic myomectomy who can give informed consent and do not have severe organ disease, chronic pain, arrhythmia, or lidocaine allergy.
Not a fit: Patients with expected surgery durations over 3 hours, those converted to open surgery, those allergic to lidocaine, or those with severe hepatic/renal/cardiac disease, chronic pain, or arrhythmia are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could reduce postoperative pain and lower the need for opioid pain medicines after laparoscopic myomectomy.
How similar studies have performed: Previous trials of either intravenous or intraperitoneal lidocaine in laparoscopic procedures have shown mixed but often favorable effects on postoperative pain.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Yinchuan, Ningxia
- General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
Study contacts
- Study coordinator: Ma Hanxaing
- Email: mahanxiang@hotmail.com
- Phone: 86-13519591508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.