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

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Procedure: Arm I (Ropivacaine-Poloxamer 407 hydrogel group); Procedure: Arm II (TAP block group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06839716

3-2024-0451

Details and patient eligibility

About

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.

Enrollment: 134 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.
5. Patients who have undergone laparoscopic or robotic gastrectomy

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: Single Blind

---

134 participants in 2 patient groups

Ropivacaine-Poloxamer 407 hydrogel group

Experimental group

Description:

Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site.

Treatment:

Procedure: Arm I (Ropivacaine-Poloxamer 407 hydrogel group)

TAP block group

Active Comparator group

Description:

Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side).

Treatment:

Procedure: Arm II (TAP block group)