RecruitingNot ApplicableNCT06778954

Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy


Sponsor

Gangnam Severance Hospital

Enrollment

48 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a slow-release local anesthetic gel (ropivacaine mixed with poloxamer 407) placed inside the abdomen during stomach cancer surgery to see if it reduces pain better than standard pain management after surgery. The gel gradually releases pain medication over time, potentially reducing the need for stronger pain drugs like opioids. **You may be eligible if...** - You have been diagnosed with stomach cancer (gastric adenocarcinoma) confirmed by biopsy - You had complete surgical removal of your stomach tumor (R0 resection) - You are 20 years of age or older - Your general health rating (ASA score) is 3 or below **You may NOT be eligible if...** - You are under 19 years of age - Your cancer has spread to the lining of the abdomen (peritoneal metastasis) or you have fluid in the abdomen - You had chemotherapy or radiation before surgery - You have another type of cancer - You have uncontrolled diabetes, autoimmune conditions, or a history of problematic scarring - You are allergic to local anesthetics - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREArm I (Peritoneal application group)

At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is applied on space between peritoneum and fascia in Arm I.

PROCEDUREArm II (Subcutaneous injection group)

At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is injected on subcutaneous area in Arm II.


Locations(1)

GangnamSeverance Hospital

Seoul, South Korea

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NCT06778954


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