Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT06778954
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-12
• Study First Posted: 2025-01-16
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption within 72 hours postoperatively.	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity scores (NRS) at rest and during movement.	Pain intensity: Measured at 24, 48, and 72 hours postoperatively.	Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement.
Time to first flatus and bowel movement.	Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)	Bowel function: Time to resume normal gastrointestinal activity.
Occurrence of postoperative nausea and vomiting (PONV).	PONV: Assessed daily for 72 hours.	PONV: Incidence of nausea and vomiting documented along with severity scores.
Wound healing assessment, including seroma and infection rates.	Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)	Wound healing: Observation of seroma or infection at the surgical site.
Length of hospital stay.	Hospital stay: up to 1 month	Hospital stay: Measured in days from surgery until patient discharge.
Quality of recovery (QoR-15).	QoR-15: Measured at baseline and 72 hours postoperatively.	QoR-15: Recovery quality assessed using a validated 15-item questionnaire.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of