Spraying low‑concentration lidocaine under the diaphragm to reduce shoulder pain after single‑port gynecologic laparoscopy
Official title: Subdiaphragmatic Infiltration of Diluted Lidocaine During Single-incision Laparoscopic Surgery for Postoperative Shoulder Pain Alleviation
Run by Peking Union Medical College Hospital · NCT07537127 · Data updated 2026-11-12
This will try spraying 0.08% lidocaine under the diaphragm at the start of single‑port laparoscopic surgery to see if it reduces immediate postoperative shoulder pain and improves mood for women having benign gynecologic operations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | August 14, 2026 |
| Study ends | August 14, 2026 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07537127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–65 with ASA I–II scheduled for elective single‑port laparoscopic surgery for benign uterine or ovarian conditions who can provide informed consent are the intended participants.
✕Probably not a fit
Patients with lidocaine or amide anesthetic allergy, severe medical comorbidities, long‑term preoperative opioid or sedative use, pregnant or breastfeeding women, or those converted to laparotomy or requiring additional ports are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single‑center, randomized controlled study at Peking Union Medical College Hospital enrolled 100 women undergoing elective single‑port laparoscopic surgery for benign gynecologic conditions (such as uterine fibroids and ovarian cysts). Participants were randomized 1:1 to receive either 50 ml of 0.08% lidocaine sprayed on the bilateral subdiaphragmatic regions at the start of surgery or standard ERAS care without additional pharmaceutical intervention. The trial measured postoperative acute pain and psychological status to determine whether the subdiaphragmatic lidocaine spray improves comfort after surgery. Patients meeting inclusion criteria were adult females (18–65 years) with ASA I–II who provided informed consent.
Why it matters
Potential benefit: If successful, this approach could reduce immediate postoperative shoulder pain and improve psychological comfort after single‑port gynecologic laparoscopy.
How similar studies have gone: Similar intraperitoneal or subdiaphragmatic local anesthetic techniques for post‑laparoscopy shoulder pain have shown mixed but promising results, so this approach builds on existing but not definitive evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: Female patients aged 18-65 years; * Clear preoperative diagnosis, suitable for single-port laparoscopic surgery, and American Society of Anesthesiologists (ASA) physical status classification I-II; * Patients or their family members can understand the study protocol, are willing to participate in the study, and provide written informed consent. Exclusion Criteria: * Allergy to lidocaine or amide-type local anesthetics; * Severe medical comorbidities; * Long-term preoperative use of opioid drugs or sedatives; * Pregnant or lactating women; * Conversion to laparotomy or addition of surgical ports during surgery.
Where it's running
-
Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Dr.
- Email: renchang@pumch.cn
- Phone: +86 18612671870
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.