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

NCT06839716 | Recruiting

• 1 other identifier: 3-2024-0451
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Total fentanyl consumption within 72 hours postoperatively.

  The total amount of fentanyl administered to the patient via IV PCA during the initial 72-hour postoperative period will be recorded and compared among groups to assess analgesic efficacy.

  Over the first 72 hours after surgery.

Secondary Outcomes (9)

• Fentanyl usage at 12, 24, 48 hours.

  Fentanyl usage at 12, 24, 48 hours.

• NRS pain scores at 24, 48, and 72 hours (at rest and during movement).

  NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).

• Pethidine usage at 24, 48, 72 hours

  Pethidine usage at 24, 48, 72 hours

• Time to first flatus and bowel movement. (up to 1 month)

  1 month

• Incidence of seroma or surgical site infection. (up to 1 month)

  1 month

Study Arms (2)

Ropivacaine-Poloxamer 407 hydrogel group

EXPERIMENTAL

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

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

TAP block group

ACTIVE COMPARATOR

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

Procedure: Arm II (TAP block group)

Interventions

Arm I (Ropivacaine-Poloxamer 407 hydrogel group) PROCEDURE

Patients receive intraoperative application of Ropivacaine-Poloxamer 407 hydrogel at the incision site. A mixture of 0.75% Ropivacaine (22.5 mg, 3 mL) and Poloxamer 407-based gel (Welpass, 6 mL) is prepared. The hydrogel is applied as 4 mL between the peritoneum and fascia, and 2 mL is injected subcutaneously around the incision before skin closure. This intervention aims to provide sustained local anesthesia for up to 72 hours.

Ropivacaine-Poloxamer 407 hydrogel group

Arm II (TAP block group) PROCEDURE

Patients undergo ultrasound-guided subcostal transversus abdominis plane (TAP) block before anesthesia emergence. A total of 30 mL of 0.375% Ropivacaine (15 mL per side) is injected bilaterally between the internal oblique and transversus abdominis muscles. TAP block is a regional anesthesia technique known for effective postoperative pain control, typically lasting 24 to 48 hours. Both groups receive standardized postoperative analgesia, including IV acetaminophen, fentanyl via patient-controlled analgesia (PCA), and rescue pethidine as needed.

TAP block group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
• Patients who have undergone a complete surgical resection (R0 resection).
• Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
• Patients aged 20 years or older.
• Patients who have undergone laparoscopic or robotic gastrectomy

You may not qualify if:

• Patients under 19 years of age.
• Presence of ascites or peritoneal metastasis.
• Patients who have undergone preoperative chemotherapy or radiotherapy.
• Diagnosis of malignancies other than gastric cancer.
• Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
• History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
• Pregnant women.
• Patients with preoperative chronic pain conditions, including CRPS.
• Patients with long-term preoperative use of opioid analgesics.
• Patients with psychiatric disorders deemed likely to interfere with study participation.
• Patients with severe liver disease, renal disease, or arrhythmia.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

In Gyu Kwon

CONTACT

82-2-2019-4601; gsirb@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single Blind Randomized controlled

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 31, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

KR (1)