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Lidocaine Spray for Postoperative Shoulder Pain in Laparoscopic Surgery

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Summary

ClinicalTrials.gov registered a randomized controlled trial (NCT07537127) at Peking Union Medical College Hospital evaluating 0.08% lidocaine spray for postoperative shoulder pain in 100 patients undergoing single-port laparoscopic gynecological surgery. The experimental group receives 50ml lidocaine sprayed on bilateral subdiaphragmatic regions; the control group receives standard ERAS protocol. Primary endpoint is NRS pain score at 6 hours postoperatively. Estimated primary completion date is April 17, 2026.

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What changed

A new clinical trial has been registered on ClinicalTrials.gov evaluating the efficacy of 0.08% lidocaine spray applied to subdiaphragmatic regions during single-port laparoscopic surgery for benign gynecological conditions. The trial will enroll 100 patients randomized to lidocaine (n=50) or standard ERAS protocol (n=50), with primary endpoint of NRS pain score at 6 hours post-surgery.

This study registration does not create compliance obligations for regulated entities. Sponsors, clinical investigators, and healthcare institutions conducting pharmaceutical or medical device trials should note this as informational registry activity with no direct regulatory implications.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Lidocaine for LESS Postoperative Shoulder Pain Alleviation

N/A NCT07537127 Kind: NA Apr 17, 2026

Abstract

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. Qu...

Conditions: Cystectomy, Myomectomy

Interventions: subdiaphragmatic lidocaine sprayed, standard ERAS

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Classification

Agency
mintz Levin
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537127

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial conduct Drug safety research
Geographic scope
CN CN

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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