Lidocaine for LESS Postoperative Shoulder Pain Alleviation

April 12, 2026 updated by: Chang Ren, Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) score at rest 6 hours postoperatively
Time Frame: From operation to 6 hours after operation
NRS: range from 0~10, with 10 the heaviest pain
From operation to 6 hours after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NRS scores at rest 1, 2, 12, and 24 hours postoperatively
Time Frame: from operation to 1, 2, 12, and 24 hours after operation
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
Time Frame: from operation to 48 hours after operation
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
Time Frame: from operation to 48 hours after operation
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
Time Frame: from operation to 48 hours after operation
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)
Time Frame: from operation to 48 hours after operation
from operation to 48 hours after operation
Distress Thermometer
Time Frame: from enrollment to 30 days after operation
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)
Time Frame: from enrollment to 30 days after operation
0-21，Higher scores indicate worse anxiety symptoms
from enrollment to 30 days after operation
Patient Health Questionnaire 2-item Scale (PHQ-2)
Time Frame: from enrollment to 30 days after operation
0-6，Higher scores indicate worse depressive symptom severity
from enrollment to 30 days after operation
Patient Health Questionnaire 9-item Scale (PHQ-9)
Time Frame: from enrollment to 30 days after operation
0-27，Higher scores indicate worse depressive symptoms
from enrollment to 30 days after operation
Impact of Event Scale - Revised (IES-R)
Time Frame: from enrollment to 30 days after operation
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)
Time Frame: from enrollment to 30 days after operation
0-21，Higher scores indicate worse sleep quality
from enrollment to 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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