Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Procedure: Arm I (Peritoneal application group); Procedure: Arm II (Subcutaneous injection group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06778954

3-2024-0383

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Peritoneal application group

Experimental group

Description:

Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia

Treatment:

Procedure: Arm I (Peritoneal application group)

Subcutaneous injection group

Experimental group

Description:

Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area

Treatment:

Procedure: Arm II (Subcutaneous injection group)

Placebo group

Placebo Comparator group

Description:

Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel

Treatment:

Procedure: Arm II (Subcutaneous injection group)

Procedure: Arm I (Peritoneal application group)