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

Not Applicable

Recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT06839716
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption within 72 hours postoperatively.	Over the first 72 hours after surgery.	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
Fentanyl usage at 12, 24, 48 hours.	Fentanyl usage at 12, 24, 48 hours.	Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement.
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).	Bowel function: Time to resume normal gastrointestinal activity.
Pethidine usage at 24, 48, 72 hours	Pethidine usage at 24, 48, 72 hours	PONV: Incidence of nausea and vomiting documented along with severity scores.
Time to first flatus and bowel movement. (up to 1 month)	1 month	The time from surgery completion to the first passage of gas and bowel movement will be recorded to assess postoperative gastrointestinal recovery.
Incidence of seroma or surgical site infection. (up to 1 month)	1 month	The presence of seroma or surgical site infection (SSI) will be evaluated through clinical examination and recorded according to standardized criteria.
Quality of Recovery (QoR-15) scores at baseline and 72 hours	72 hours postoperatively	Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire, which evaluates physical comfort, emotional state, and overall well-being.(Quality of Recovery (QoR-15) score 0-10 on each items/ 0: worst recovery / 10: best recovery)
Peak Cough Flow (baseline and 72 hours)	Baseline (preoperatively) and 72 hours postoperatively	Peak cough flow (PCF) will be measured using a peak flow meter to assess respiratory function and recovery after surgery.
Length of hospital stay. (up to 1 month)	up to 1 month	The total number of days from surgery to hospital discharge will be recorded to evaluate recovery speed and efficiency.
Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)	72 hours postoperatively	The occurrence of postoperative nausea and vomiting (PONV) will be documented, and severity will be assessed using a standardized scale.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of