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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Arm I (Ropivacaine-Poloxamer 407 hydrogel group); Procedure: Arm II (TAP block group)

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In Gyu Kwon; Phone Number: 82-2-2019-4601; Email: gsirb@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Shiyeol Jun; Phone Number: 82-2-2019-4601; Email: gsirb@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine-Poloxamer 407 hydrogel group; Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site.	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.
Active Comparator: TAP block group; Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side).	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-controlled analgesia (PCA), and rescue pethidine as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Fentanyl usage at 12, 24, 48 hours.
Pethidine usage at 24, 48, 72 hours	PONV: Incidence of nausea and vomiting documented along with severity scores.	Pethidine usage at 24, 48, 72 hours
Time to first flatus and bowel movement. (up to 1 month)	The time from surgery completion to the first passage of gas and bowel movement will be recorded to assess postoperative gastrointestinal recovery.	1 month
Incidence of seroma or surgical site infection. (up to 1 month)	The presence of seroma or surgical site infection (SSI) will be evaluated through clinical examination and recorded according to standardized criteria.	1 month
Peak Cough Flow (baseline and 72 hours)	Peak cough flow (PCF) will be measured using a peak flow meter to assess respiratory function and recovery after surgery.	Baseline (preoperatively) and 72 hours postoperatively
Length of hospital stay. (up to 1 month)	The total number of days from surgery to hospital discharge will be recorded to evaluate recovery speed and efficiency.	up to 1 month
Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)	The occurrence of postoperative nausea and vomiting (PONV) will be documented, and severity will be assessed using a standardized scale.	72 hours postoperatively
NRS pain scores at 24, 48, and 72 hours (at rest and during movement).	Bowel function: Time to resume normal gastrointestinal activity.	NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).
Quality of Recovery (QoR-15) scores at baseline and 72 hours	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)	72 hours postoperatively

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: 3-2024-0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No