Comparison of the Postoperative Analgesic Effects of the Temperature-responsive Gel Mixed With Local Anesthetics Application and Ultrasound-guided Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Gastrectomy
TAP-WELPASS
2 other identifiers
interventional
80
1 country
1
Brief Summary
This study is a single-center, prospective, randomized controlled trial designed to compare two established postoperative analgesic strategies in adult patients undergoing laparoscopic gastrectomy under general anesthesia. Effective pain control after laparoscopic gastrectomy is essential to promote early recovery, facilitate ambulation, reduce opioid consumption, and improve overall postoperative outcomes. Although minimally invasive techniques reduce surgical trauma, patients frequently experience moderate postoperative pain arising from abdominal wall incisions and trocar insertion sites. This trial compares two analgesic approaches: Ultrasound-guided bilateral transversus abdominis plane (TAP) block using 0.2% ropivacaine Local application of a thermosensitive ropivacaine-poloxamer 407 hydrogel formulation (Welpass®) applied to the surgical site at the end of surgery A total of 80 patients (age ≥19 years, American Society of Anesthesiologists physical status I-III) scheduled for elective laparoscopic gastrectomy will be enrolled at a single institution. Participants will be randomly assigned in a 1:1 ratio to either the TAP block group (n=40) or the hydrogel group (n=40). In the TAP block group, 0.2% ropivacaine will be injected bilaterally between the internal oblique and transversus abdominis muscles under ultrasound guidance at the completion of surgery. In the hydrogel group, a mixture of ropivacaine and poloxamer 407-based gel (Welpass®) will be prepared and applied locally to the surgical site, including the fascial plane and subcutaneous tissue, prior to wound closure. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia (PCA) according to institutional protocols. The primary objective of the study is to compare postoperative pain intensity between the two groups. Pain will be assessed using the Visual Analog Scale (VAS) immediately upon arrival in the post-anesthesia care unit (PACU), just before PACU discharge, and at 12 and 24 hours after surgery. Secondary outcomes include:
- Total PCA consumption within 48 hours
- Additional analgesic use (total dose and frequency)
- Time to first flatus
- Time to ambulation
- Length of hospital stay
- Incidence of postoperative nausea and vomiting (PONV) Safety will be evaluated by monitoring adverse events, including signs of local anesthetic systemic toxicity or other serious complications. Both analgesic techniques involve medications and procedures that are widely used in routine clinical practice. The study uses approved drugs within standard dosing ranges and is conducted by experienced clinicians. If a serious adverse event suspected to be related to the intervention occurs, appropriate medical management will be provided immediately, and the Institutional Review Board (IRB) will be notified in accordance with regulatory requirements. Participants may be withdrawn from the study if they experience a serious adverse reaction related to the intervention, if conversion to open surgery occurs, or if they choose to withdraw consent. The aim of this study is to determine whether local application of sustained-release ropivacaine hydrogel provides analgesic efficacy comparable or superior to ultrasound-guided TAP block. The findings may help identify an effective and safe postoperative pain management strategy for patients undergoing laparoscopic gastrectomy and contribute to optimizing multimodal analgesia protocols in minimally invasive gastric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable gastric-cancer
Started Feb 2026
Shorter than P25 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2026
CompletedFirst Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 11, 2027
March 5, 2026
February 1, 2026
12 months
February 20, 2026
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Intensity
Postoperative pain intensity measured using the Visual Analog Scale (VAS, 0-10) immediately upon arrival in the post-anesthesia care unit (PACU) and just before PACU discharge. The VAS ranges from 0 (no pain) to 10 (worst imaginable pain). Mean pain scores will be compared between the two groups
postoperative period(immediately upon arrival in PACU, at PACU discharge, 12,24 hours after surgery)
Secondary Outcomes (7)
Total Patient-Controlled Analgesia (PCA) Consumption
48 hours postoperatively
Total Rescue Analgesic Dose
48 hours postoperatively
Number of Rescue Analgesic Administrations
48 hours postoperatively
Number of PONV Episodes
48 hours postoperatively
Time to First Flatus
From the end of surgery until the first documented passage of flatus, assessed up to 7 days postoperatively
- +2 more secondary outcomes
Study Arms (2)
TAP Block Group
ACTIVE COMPARATORParticipants receive bilateral ultrasound-guided transversus abdominis plane (TAP) block with 0.2% ropivacaine at the completion of laparoscopic gastrectomy. Standardized general anesthesia and postoperative patient-controlled analgesia (PCA) are provided
Ropivacaine-Poloxamer Hydrogel Group
EXPERIMENTALParticipants receive local application of ropivacaine-poloxamer 407 thermosensitive hydrogel (Welpass®) at the surgical site following laparoscopic gastrectomy. Standardized general anesthesia and postoperative PCA are provided
Interventions
Bilateral ultrasound-guided injection of 0.2% ropivacaine between the internal oblique and transversus abdominis muscles at the end of surgery
Local application of a thermosensitive hydrogel containing ropivacaine and poloxamer 407 to the fascial and subcutaneous layers at the surgical site prior to wound closure
Eligibility Criteria
You may qualify if:
- Adults aged 19 years or older undergoing laparoscopic gastrectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
You may not qualify if:
- Known hypersensitivity or allergy to local anesthetics
- Presence of autoimmune disease or dermatologic conditions such as keloids
- Conversion from laparoscopic surgery to open surgery
- Pregnant women
- Chronic opioid use for persistent pain
- Inability to communicate effectively, making pain assessment difficult
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yangsan Pusan National University Hospital
Yangsan, Gyeongsamnamdo, 50612, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor for fund
Study Record Dates
First Submitted
February 20, 2026
First Posted
March 5, 2026
Study Start
February 12, 2026
Primary Completion (Estimated)
February 11, 2027
Study Completion (Estimated)
February 11, 2027
Last Updated
March 5, 2026
Record last verified: 2026-02