Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD)

Objective: To investigate the analgesic effect and safety of intradermal needle therapy for patients after gastric endoscopic submucosal dissection (ESD).

Methods: Patients undergoing gastric endoscopic submucosal dissection (ESD) treatment at a digestive endoscopy center in Lanzhou, Gansu Province, starting in March 2025, were selected as the subjects of this study.

• Research Design: Inclusion and exclusion criteria for patients undergoing gastric endoscopic submucosal dissection (ESD) were established for screening purposes. Selected patients signed informed consent forms. Following endoscopic submucosal dissection (ESD) , patients were randomly divided into a treatment group and a control group at a 1:1 ratio based on a random number table. The treatment group received intradermal needle therapy in addition to conventional treatment, administered uniformly by trained nursing staff. The control group received conventional treatment only. Both the anesthesiologist and the endoscopic surgeon involved in the procedure were blinded to the group allocation. However, due to the particularity of the intradermal needle therapy, it was not possible to blind the patients.
• Data collection: Patient demographic data (age, gender, height, weight, comorbidities, smoking, and drinking status), clinicopathological characteristics (location, depth, and pathological classification), and surgery-related information (duration of surgery, surgery-related complications) were collected. Additionally, the occurrence of nausea, vomiting, and abdominal distension during the trial, the location of pain, and the levels of white blood cells and C-reactive protein on the first postoperative day were recorded.
• Outcomes: The primary outcome of the clinical trial was the incidence of moderate-to-severe pain within 72 hours postoperatively. Secondary outcomes included VAS pain scores at various time points (1h, 6h, 12h, 24h, 48h, and 72h postoperatively), Simplified McGill Pain Score (SF-MPQ), use of analgesic medications, preoperative and postoperative SAS and SDS scores, postoperative recovery status (including hospital stay duration and time of first postoperative flatulence), surgical complications (such as fever, bleeding, and perforation), and safety evaluation of intradermal needle therapy (including adverse reactions such as dizziness, skin allergy, skin damage, infection, hematoma, local pain, or other discomforts at the puncture site, or needle breakage).
• Sample Size Calculation: The sample size calculation was based on the findings from a preliminary experiment, where the incidence of moderate-to-severe postoperative pain was 10% in the treatment group and 40% in the control group. This difference was used to calculate the required sample size to detect clinically significant differences between the groups using PASS.2021 software. With a type 1 error probability of 0.05 (α = 0.05), a type 2 error probability of 0.2 (β = 0.2), and a power of 0.80 for a two-sided comparison and based on the aforementioned between-group difference in the incidence of moderate-to-severe postoperative pain, we determined that 64 patients were required in each group. Accounting for a 20% lost-to-follow-up rate and a 1:1 enrollment ratio, a total sample size of 78 patients (39 in each group) was included in the study.

Inclusion criteria

All patients who signed informed consent after gastric ESD were enrolled in this study.

Exclusion criteria

• Patients who pulled out the needles in advance;
• Individuals with psychiatric disorders, impaired communication abilities, or difficulties in self-assessment of pain.