Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06839716

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
134 (estimated)
Sponsor
Gangnam Severance Hospital · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREArm 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.
PROCEDUREArm 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.

Timeline

Start date
2025-02-01
Primary completion
2026-02-01
Completion
2026-03-31
First posted
2025-02-21
Last updated
2025-02-25

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06839716. Inclusion in this directory is not an endorsement.