Subdiaphragmatic Infiltration of Diluted Lidocaine During Single-incision Laparoscopic Surgery for Postoperative Shoulder Pain Alleviation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Numerical Rating Scale (NRS) score at rest 6 hours postoperatively
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: subdiaphragmatic lidocaine sprayed (Other)
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.
Intervention: standard ERAS (Procedure)
Outcomes
Primary Outcomes
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
- NRS scores at rest 1, 2, 12, and 24 hours postoperatively(from operation to 1, 2, 12, and 24 hours after operation)
- Total consumption of postoperative analgesic drugs：type of additional postoperative analgesic drugs(from operation to 48 hours after operation)
- Total consumption of postoperative analgesic drugs： dosage of additional postoperative analgesic drugs(from operation to 48 hours after operation)
- Incidence of postoperative nausea and 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(from enrollment to 30 days after operation)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(from enrollment to 30 days after operation)
- Patient Health Questionnaire 2-item Scale (PHQ-2)(from enrollment to 30 days after operation)
- Patient Health Questionnaire 9-item Scale (PHQ-9)(from enrollment to 30 days after operation)
- Impact of Event Scale - Revised (IES-R)(from enrollment to 30 days after operation)
- Pittsburgh Sleep Quality Index (PSQI)(from enrollment to 30 days after operation)
Investigators
Chang Ren
associate chief physician
Peking Union Medical College Hospital