Spraying low‑concentration lidocaine under the diaphragm to reduce shoulder pain after single‑port gynecologic laparoscopy

Subdiaphragmatic Infiltration of Diluted Lidocaine During Single-incision Laparoscopic Surgery for Postoperative Shoulder Pain Alleviation

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07537127 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dr.

Conditions Cystectomy; Myomectomy