Comparing two methods for managing pain after gastric cancer surgery
Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy
This study is testing whether a new pain relief gel works as well as a common injection method for people recovering from gastric cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06839716 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Ropivacaine-Poloxamer 407 hydrogel in controlling postoperative pain compared to the TAP block technique for patients undergoing laparoscopic or robotic gastrectomy due to gastric cancer. The goal is to determine if the hydrogel provides similar pain relief, which could influence future pain management protocols and enhance recovery for these patients. Participants will be randomly assigned to one of the two treatment arms to assess outcomes related to pain control and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with a confirmed diagnosis of gastric adenocarcinoma who are undergoing laparoscopic or robotic gastrectomy.
Not a fit: Patients with other malignancies, uncontrolled chronic conditions, or those who have undergone preoperative chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing surgery for gastric cancer.
How similar studies have performed: Previous studies have shown promising results with similar pain management approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: In Gyu Kwon
- Email: gsirb@yuhs.ac
- Phone: 82-2-2019-4601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.