Actively Recruiting
Subdiaphragmatic Infiltration of Diluted Lidocaine During Single-incision Laparoscopic Surgery for Postoperative Shoulder Pain Alleviation
Led by Peking Union Medical College Hospital · Updated on 2026-04-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a low-concentration lidocaine spray applied under the diaphragm during single-port laparoscopic surgery to relieve postoperative acute pain and improve psychological status in women undergoing surgery for benign gynecological conditions such as uterine fibroids and ovarian cysts. This randomized controlled study aims to provide evidence that could improve pain management after these surgeries. Participants are randomly assigned to one of two groups. The experimental group receives 50 ml of 0.08% lidocaine sprayed on the diaphragm area during surgery through a catheter inserted via the laparoscopic port. The control group follows a standard Enhanced Recovery After Surgery (ERAS) protocol without any lidocaine spray. Both groups undergo the same surgical procedure but differ in the subdiaphragmatic treatment. During the study, participants will have their pain levels measured at several time points up to 24 hours after surgery using a Numerical Rating Scale. The study also tracks total analgesic use, adverse reactions, patient satisfaction, and psychological and sleep assessments up to 30 days after surgery. Data will be analyzed to compare pain relief and psychological outcomes between the two groups, helping to guide future postoperative pain management strategies.
CONDITIONS
Brief Title
Lidocaine for LESS Postoperative Shoulder Pain Alleviation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 65 years
- Clear preoperative diagnosis suitable for single-port laparoscopic surgery
- American Society of Anesthesiologists (ASA) physical status classification I-II
- Able to understand the study protocol and provide written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after surgery
Participants undergo single-incision laparoscopic surgery during which they receive either subdiaphragmatic lidocaine spray or standard Enhanced Recovery After Surgery (ERAS) protocol without lidocaine. Postoperative pain and analgesic use are monitored closely.
Continuous monitoring during hospital stay with assessments at 1, 2, 6, 12, 24, and 48 hours postoperatively
Duration - 30 days after surgery
Participants are followed for 30 days after surgery to assess psychological health, sleep quality, and overall recovery.
Scheduled assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Peking Union Medical College
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
D
Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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