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NCT Number: NCT07537127

Lidocaine for LESS 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

subdiaphragmatic lidocaine sprayed

Other

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 ERAS

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Incidence of postoperative nausea and vomiting

    Time frame: from operation to 48 hours after operation

    incidence of postoperative nausea or vomiting

  5. 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

  6. Distress Thermometer

    Time frame: from enrollment to 30 days after operation

    Distress Thermometer (DT),0-10,Higher scores indicate worse condition.

  7. 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

  8. 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

  9. 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

  10. 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)

  11. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: from enrollment to 30 days after operation

    0-21,Higher scores indicate worse sleep quality

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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