Lidocaine for LESS Postoperative Shoulder Pain Alleviation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myomectomy; Cystectomy
• Intervention / Treatment: Other: subdiaphragmatic lidocaine sprayed; Procedure: standard ERAS

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr.; Phone Number: +86 18612671870; Email: renchang@pumch.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College
      • Contact: Chang Ren; Phone Number: 086-13488698861; Email: daphneren@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subdiaphragmatic lidocaine spray; 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; 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.
Placebo Comparator: standard ERAS; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) score at rest 6 hours postoperatively	NRS: range from 0~10, with 10 the heaviest pain	From operation to 6 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS scores at rest 1, 2, 12, and 24 hours postoperatively	NRS: range from 0~10, with 10 the heaviest pain	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	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	from operation to 48 hours after operation
Incidence of postoperative nausea and vomiting	incidence of postoperative nausea or vomiting	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)		from operation to 48 hours after operation
Distress Thermometer	Distress Thermometer (DT)，0-10，Higher scores indicate worse condition.	from enrollment to 30 days after operation
Generalized Anxiety Disorder 7-item Scale (GAD-7)	0-21，Higher scores indicate worse anxiety symptoms	from enrollment to 30 days after operation
Patient Health Questionnaire 2-item Scale (PHQ-2)	0-6，Higher scores indicate worse depressive symptom severity	from enrollment to 30 days after operation
Patient Health Questionnaire 9-item Scale (PHQ-9)	0-27，Higher scores indicate worse depressive symptoms	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)	from enrollment to 30 days after operation
Pittsburgh Sleep Quality Index (PSQI)	0-21，Higher scores indicate worse sleep quality	from enrollment to 30 days after operation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DKFQJGXJRMZ-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No