Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy

Last updated: February 23, 2025
Sponsor: Gangnam Severance Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Treatment

Arm I (Ropivacaine-Poloxamer 407 hydrogel group)

Arm II (TAP block group)

Clinical Study ID

NCT06839716
3-2024-0451
  • Ages > 20
  • All Genders

Study Summary

This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma priorto 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.

  5. Patients who have undergone laparoscopic or robotic gastrectomy

Exclusion

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 historyaffecting 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 studyparticipation.

  11. Patients with severe liver disease, renal disease, or arrhythmia.

Study Design

Total Participants: 134
Treatment Group(s): 2
Primary Treatment: Arm I (Ropivacaine-Poloxamer 407 hydrogel group)
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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