Menu
Recruiting NCT06839716

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

No phase Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arm I (Ropivacaine-Poloxamer 407 hydrogel group), Arm II (TAP block group).
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy

Overview

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.

Interventions

  • Procedure Arm I (Ropivacaine-Poloxamer 407 hydrogel group)
    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.
  • Procedure Arm II (TAP block group)
    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-control

Primary outcome measures

  • Total fentanyl consumption within 72 hours postoperatively. [Time frame: Over the first 72 hours after surgery.]
Secondary outcome measures (9)
  • Fentanyl usage at 12, 24, 48 hours. [Time frame: Fentanyl usage at 12, 24, 48 hours.]
  • NRS pain scores at 24, 48, and 72 hours (at rest and during movement). [Time frame: 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 [Time frame: Pethidine usage at 24, 48, 72 hours]
  • Time to first flatus and bowel movement. (up to 1 month) [Time frame: 1 month]
  • Incidence of seroma or surgical site infection. (up to 1 month) [Time frame: 1 month]
  • Quality of Recovery (QoR-15) scores at baseline and 72 hours [Time frame: 72 hours postoperatively]
  • Peak Cough Flow (baseline and 72 hours) [Time frame: Baseline (preoperatively) and 72 hours postoperatively]
  • Length of hospital stay. (up to 1 month) [Time frame: up to 1 month]
  • Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours) [Time frame: 72 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Gangnam Severance Hospital — Seoul

Identifiers

NCT: NCT06839716 · 3-2024-0451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗