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

NCT06828250 | Completed

• 1 other identifier: INT001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to explore the analgesic effect of intradermal needle therapy on patients after gastric endoscopic submucosal dissection, and evaluate the safety of intradermal needle therapy. The primary questions it aims to address are:

1. 1.What is the incidence of moderate-to-severe pain after gastric endoscopic submucosal dissection (ESD)? What is the incidence of moderate-to-severe pain after treatment with intradermal needle therapy?
2. 2.What adverse reactions do patients experience after treatment with intradermal needle therapy?
3. 3.Does intradermal needle therapy alleviate postoperative pain in patients undergoing gastric endoscopic submucosal dissection (ESD)?
4. 4.Postoperatively, patients were randomly assigned to a treatment group and a control group. In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days. The control group received conventional postoperative treatment.
5. 5.Researchers will record the incidence of moderate-to-severe pain within 72 hours postoperatively using the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points). VAS pain scores and Simplified McGill Pain Questionnaire (SF-MPQ) scores will be assessed at 1h, 6h, 12h, 24h, 48h, and 72h postoperatively. The use of analgesic medications will also be noted. Preoperative and postoperative SAS and SDS scores will be documented, along with postoperative recovery details such as length of hospital stay , and surgical complications (such as fever, bleeding, and perforation). Additionally, the safety evaluation of intradermal needle therapy will include monitoring for adverse events such as dizziness, skin irritation, skin breakage, infection, hematoma, local pain or discomfort at the puncture site, or needle breakage.
6. 6.The baseline characteristics of patients will be recorded, and factors associated with postoperative pain after gastric endoscopic submucosal dissection (ESD) (including demographic data, clinicopathological features, surgical conditions, etc.) will be analyzed.

Conditions

Endoscopic Submucosal Dissection (ESD)

Outcome Measures

Primary Outcomes (1)

• the incidence of moderate-to-severe pain within 72 hours postoperatively

  the VAS pain score (no pain: 0 points, mild: 1-3 points, moderate: 4-6 points, severe: 7-10 points).

  72 hours postoperatively

Study Arms (2)

intradermal needle therapy

EXPERIMENTAL

In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days.

Device: intradermal needle therapy

conventional treatment

NO INTERVENTION

The control group received conventional postoperative treatment

Interventions

intradermal needle therapy DEVICE

In addition to conventional treatment, patients in the treatment group received intradermal needle therapy within 1 hour after surgery. Bilateral Hegu (LI4) and Zusanli (ST36) acupoints were selected for this therapy. Patients were positioned in a supine position, and after locating the acupoints, the skin of the acupoint areas was sterilized with 75% ethanol using a medical cotton swab. The intradermal needle was then removed along with the adhesive tape, inserted into the acupoints, and pressed every 4 hours for approximately 60 presses each time, excluding nighttime sleep. The pressure was applied until an acid, swelling, or numb sensation was felt at each acupoint. The intradermal needle therapy was administered only once and continuously pressed for 3 days.

intradermal needle therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Key Laboratory for Gastrointestinal Diseases of Gansu Province: lead

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the anesthesiologist and the endoscopic surgeon involved in the procedure were blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 15, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)