Using Ropivacaine-Poloxamer 407 Gel to Manage Pain After Stomach Surgery
Official title: Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy
Run by Gangnam Severance Hospital · NCT06778954 · Data updated 2026-11-12
This study tests if a special pain-relief gel used after stomach surgery can help patients feel less pain and recover better compared to a regular injection.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | November 1, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 14, 2025 |
| Trial ID | NCT06778954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20 and older with a confirmed diagnosis of gastric adenocarcinoma who are undergoing complete surgical resection.
✕Probably not a fit
Patients with other malignancies, those who have undergone preoperative chemotherapy or radiotherapy, or individuals with uncontrolled chronic pain conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Ropivacaine-Poloxamer 407 hydrogel in alleviating postoperative pain in patients who have undergone open gastrectomy for gastric cancer. Participants will be divided into two groups: one receiving the gel applied directly to the peritoneum and the other receiving a subcutaneous injection. The goal is to determine which method provides better pain control after surgery. The study aims to improve postoperative recovery and patient comfort.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery times for patients undergoing open gastrectomy.
How similar studies have gone: While the specific combination of Ropivacaine and Poloxamer 407 is novel, similar studies using local anesthetics for postoperative pain management have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery. 2. Patients who have undergone a complete surgical resection (R0 resection). 3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below. 4. Patients aged 20 years or older. Exclusion Criteria: 1. Patients under 19 years of age. 2. Presence of ascites or peritoneal metastasis. 3. Patients who have undergone preoperative chemotherapy or radiotherapy. 4. Diagnosis of malignancies other than gastric cancer. 5. Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing. 6. History of allergy or adverse reactions to Ropivacaine or other local anesthetics. 7. Pregnant women. 8. Patients with preoperative chronic pain conditions, including CRPS. 9. Patients with long-term preoperative use of opioid analgesics. 10. Patients with psychiatric disorders deemed likely to interfere with study participation. 11. Patients with severe liver disease, renal disease, or arrhythmia.
Where it's running
-
GangnamSeverance Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Shiyeol Jun
- Email: gsirb@yuhs.ac
- Phone: 82-2-2019-4601
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.