An interventional study of subdiaphragmatic lidocaine sprayed and standard ERAS in Cystectomy and Myomectomy, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Prevention
Objective: To evaluate the efficacy of subdiaphragmatic spray of 0.08% lidocaine in relieving postoperative acute pain and psychological status of patients undergoing single-port laparoscopic surgery for benign gynecological diseases, and to provide evidence-based basis for optimizing postoperative analgesic strategies.
Methods: A single-center, prospective randomized controlled study was conducted. A total of 100 patients scheduled for elective single-port laparoscopic surgery due to uterine fibroids, ovarian cysts, or other benign gynecological conditions were selected from the General Gynecology Center of Peking Union Medical College Hospital. They were divided into the experimental group (n=50) and the control group (n=50) using a random number table. The experimental group received 50 ml of 0.08% lidocaine solution sprayed on the bilateral subdiaphragmatic regions at the start of surgery, while the control group underwent standard ERAS without any pharmaceutical intervention in the subdiaphragmatic area. The primary endpoint was the Numerical Rating Scale (NRS) score for resting pain at 6 hours postoperatively. The secondary endpoints included NRS scores at 1, 2, 12, and 24 hours postoperatively, total consumption of analgesics within 48 hours after surgery, incidence of adverse reactions, patient satisfaction, and scores of psychological and sleep scales (Distress Thermometer, GAD-7, etc.) at 30 days postoperatively. SPSS 25.0 software was used for data analysis. Quantitative data were analyzed by t-test or Mann-Whitney U test, and qualitative data were analyzed by χ² test or Fisher's exact test. Repeated measurement data were analyzed by repeated measures analysis of variance.
Results: After the completion of the study, differences in NRS scores, analgesic consumption, psychological status and other indicators between the two groups will be compared.
Conclusion: The results of this study will clarify the clinical value of intraoperative diaphragmatic infiltration with low-concentration lidocaine in postoperative analgesia after single-port laparoscopic gynecological surgery, and provide references for postoperative pain management and psychological intervention.
Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
After adjusting the patient's position, a catheter is inserted through the single-port laparoscopic operating channel, and 50ml of 0.08% lidocaine solution is evenly sprayed on the bilateral subdiaphragmatic regions under laparoscopic direct vision.
Other: subdiaphragmatic lidocaine sprayed
Standard Enhanced Recovery After Surgery (ERAS) protocol for single-port laparoscopic surgery is performed, with no drug intervention in the subdiaphragmatic region at the end of surgery.
Procedure: standard ERAS
After adjusting the patient's position, a catheter is inserted through the single-port laparoscopic operating channel, and 50ml of 0.08% lidocaine solution is evenly sprayed on the bilateral subdiaphragmatic regions under laparoscopic direct vision.
Standard Enhanced Recovery After Surgery (ERAS) protocol for single-port laparoscopic surgery is performed, with no drug intervention in the subdiaphragmatic region at the end of surgery.
Numerical Rating Scale (NRS) score at rest 6 hours postoperatively
NRS: range from 0\~10, with 10 the heaviest pain
Time frame: From operation to 6 hours after operation
NRS scores at rest 1, 2, 12, and 24 hours postoperatively
NRS: range from 0\~10, with 10 the heaviest pain
Time frame: from operation to 1, 2, 12, and 24 hours after operation
Total consumption of postoperative analgesic drugs：type of additional postoperative analgesic drugs
type of additional postoperative analgesic drugs used after operation, besides standard ERAS protocol
Time frame: from operation to 48 hours after operation
Total consumption of postoperative analgesic drugs： dosage of additional postoperative analgesic drugs
dosage of additional postoperative analgesic drugs used after operation, besides standard ERAS protocol
Time frame: from operation to 48 hours after operation
Incidence of postoperative nausea and vomiting
incidence of postoperative nausea or vomiting
Time frame: from operation to 48 hours after operation
Overall patient satisfaction score with postoperative analgesic effect (using a 5-point Likert scale, including five levels: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied)
Time frame: from operation to 48 hours after operation
Distress Thermometer
Distress Thermometer (DT)，0-10，Higher scores indicate worse condition.
Time frame: from enrollment to 30 days after operation
Generalized Anxiety Disorder 7-item Scale (GAD-7)
0-21，Higher scores indicate worse anxiety symptoms
Time frame: from enrollment to 30 days after operation
Patient Health Questionnaire 2-item Scale (PHQ-2)
0-6，Higher scores indicate worse depressive symptom severity
Time frame: from enrollment to 30 days after operation
Patient Health Questionnaire 9-item Scale (PHQ-9)
0-27，Higher scores indicate worse depressive symptoms
Time frame: from enrollment to 30 days after operation
Impact of Event Scale - Revised (IES-R)
0-88，Higher scores indicate worse post-traumatic stress symptoms (intrusions, avoidance, hyperarousal)
Time frame: from enrollment to 30 days after operation
Pittsburgh Sleep Quality Index (PSQI)
0-21，Higher scores indicate worse sleep quality
Time frame: from enrollment to 30 days after operation
Plan to share: No
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Peking Union Medical College Hospital