Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy
NCT ID: NCT06778954
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-01-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Peritoneal application group
Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia
Arm 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.
Subcutaneous injection group
Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area
Arm 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.
Placebo group
Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel
Arm 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.
Arm 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.
Interventions
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Arm 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.
Arm 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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In Gyu Kwon
Assistant Professor
Locations
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GangnamSeverance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Shiyeol Jun
Role: primary
Other Identifiers
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3-2024-0383
Identifier Type: -
Identifier Source: org_study_id
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