CystectomyNCT07537127
Lidocaine for LESS Postoperative Shoulder Pain Alleviation
A study testing subdiaphragmatic lidocaine sprayed and standard ERAS in people with Cystectomy and Myomectomy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cystectomy, Myomectomy
- What is being tested?
- subdiaphragmatic lidocaine sprayed and standard ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 14 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College
Beijing, Beijing Municipality, 100730
Chang Ren, 086-13488698861, daphneren@163.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Cystectomy, Myomectomy
- Being tested
- subdiaphragmatic lidocaine sprayed, standard ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subdiaphragmatic lidocaine sprayedOther
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 ERASProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| subdiaphragmatic lidocaine spray | Experimental | 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. Receives: Other: subdiaphragmatic lidocaine sprayed |
| standard ERAS | Placebo comparator | 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. Receives: Procedure: standard ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) score at rest 6 hours postoperatively
NRS: range from 0~10, with 10 the heaviest pain
Measured: From operation to 6 hours after operation
Secondary outcomes (11)
NRS scores at rest 1, 2, 12, and 24 hours postoperatively
NRS: range from 0~10, with 10 the heaviest pain
Measured: 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
Measured: 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
Measured: from operation to 48 hours after operation
Incidence of postoperative nausea and vomiting
incidence of postoperative nausea or vomiting
Measured: 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)
Measured: from operation to 48 hours after operation
Distress Thermometer
Distress Thermometer (DT)，0-10，Higher scores indicate worse condition.
Measured: from enrollment to 30 days after operation
Generalized Anxiety Disorder 7-item Scale (GAD-7)
0-21，Higher scores indicate worse anxiety symptoms
Measured: from enrollment to 30 days after operation
Patient Health Questionnaire 2-item Scale (PHQ-2)
0-6，Higher scores indicate worse depressive symptom severity
Measured: from enrollment to 30 days after operation
Patient Health Questionnaire 9-item Scale (PHQ-9)
0-27，Higher scores indicate worse depressive symptoms
Measured: 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)
Measured: from enrollment to 30 days after operation
Pittsburgh Sleep Quality Index (PSQI)
0-21，Higher scores indicate worse sleep quality
Measured: from enrollment to 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Dec 2025
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystectomyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ren, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537127
- Sponsor's protocol ID
- DKFQJGXJRMZ-1
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subdiaphragmatic Infiltration of Diluted Lidocaine During Single-incision Laparoscopic Surgery for Postoperative Shoulder Pain Alleviation
- ClinicalTrials.gov ID
- NCT07537127
- Acronym / sponsor ID
- DKFQJGXJRMZ-1
- Conditions
- Cystectomy, Myomectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subdiaphragmatic lidocaine spray | Experimental | Other: subdiaphragmatic lidocaine sprayedAfter 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 | Placebo comparator | Procedure: standard ERASStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subdiaphragmatic lidocaine sprayedAfter 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 spray |
| standard ERASStandard 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 or surgery | standard ERAS |
Primary outcome
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
11 secondary outcomes
NRS scores at rest 1, 2, 12, and 24 hours postoperatively
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
Time frame: 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
Incidence of postoperative nausea and 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
Time frame: from enrollment to 30 days after operation
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: from enrollment to 30 days after operation
Patient Health Questionnaire 2-item Scale (PHQ-2)
Time frame: from enrollment to 30 days after operation
Patient Health Questionnaire 9-item Scale (PHQ-9)
Time frame: from enrollment to 30 days after operation
Impact of Event Scale - Revised (IES-R)
Time frame: from enrollment to 30 days after operation
Pittsburgh Sleep Quality Index (PSQI)
Time frame: from enrollment to 30 days after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subdiaphragmatic lidocaine sprayed and standard ERAS in people with Cystectomy and Myomectomy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. (+86 18612671870, renchang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) score at rest 6 hours postoperatively (time frame: From operation to 6 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.