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Not yet recruitingNCT07452471TAP-WELPASSUpdated Mar 5, 2026

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

An interventional study of Ultrasound-guided Transversus Abdominis Plane (TAP) Block and Ropivacaine-Poloxamer 407 Hydrogel (Welpass®) in Gastric Cancer and Postoperative Pain, sponsored by Gyeong-Jo Byeon, MD, PhD. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Gyeong-Jo Byeon, MD, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Gastric Cancer
  • Postoperative Pain
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 80 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

This is the only study on the registry with Gyeong-Jo Byeon, MD, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 19 years or older undergoing laparoscopic gastrectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    TAP Block Group

    Participants 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

    Procedure: Ultrasound-guided Transversus Abdominis Plane (TAP) Block

  • Experimental
    Ropivacaine-Poloxamer Hydrogel Group

    Participants 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

    Drug: Ropivacaine-Poloxamer 407 Hydrogel (Welpass®)

Interventions

  • ProcedureUltrasound-guided Transversus Abdominis Plane (TAP) Block

    Bilateral ultrasound-guided injection of 0.2% ropivacaine between the internal oblique and transversus abdominis muscles at the end of surgery

  • DrugRopivacaine-Poloxamer 407 Hydrogel (Welpass®)

    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

06

What researchers measure

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

    Time frame: postoperative period(immediately upon arrival in PACU, at PACU discharge, 12,24 hours after surgery)

Secondary outcomes

  1. Total Patient-Controlled Analgesia (PCA) Consumption

    Total cumulative dose of intravenous patient-controlled analgesia administered during the first 48 hours after surgery.

    Time frame: 48 hours postoperatively

  2. Total Rescue Analgesic Dose

    Total cumulative dose of additional rescue analgesics administered within 48 hours after surgery.

    Time frame: 48 hours postoperatively

  3. Number of Rescue Analgesic Administrations

    Total number of additional rescue analgesic administrations within 48 hours after surgery.

    Time frame: 48 hours postoperatively

  4. Number of PONV Episodes

    Total number of postoperative nausea and vomiting episodes occurring within 48 hours after surgery.

    Time frame: 48 hours postoperatively

  5. Time to First Flatus

    Time from the end of surgery to the first passage of flatus, measured in hours.

    Time frame: From the end of surgery until the first documented passage of flatus, assessed up to 7 days postoperatively

  6. Time to First Ambulation

    Time from the end of surgery to first ambulation, measured in hours.

    Time frame: From end of surgery to first ambulation, assessed up to 7 postoperative days

  7. Length of Postoperative Hospital Stay

    Duration of hospitalization from the date of surgery to the date of discharge, measured in days.

    Time frame: From date of surgery to date of discharge, assessed up to 30 days postoperatively

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Study locations

1 site
  • Yangsan Pusan National University Hospital
    Yangsan, Gyeongsamnamdo 50612, South Korea
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References and documents

Individual participant data

Plan to share: Undecided — Individual participant data will not be shared due to institutional policies and restrictions outlined in the informed consent process. The study is a single-center clinical trial, and no plans for public data repository submission have been established

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07452471
Lead sponsor
Gyeong-Jo Byeon, MD, PhD
Responsible party
Gyeong-Jo Byeon, MD, PhD (Associate professor for fund, Pusan National University Yangsan Hospital) — Sponsor-investigator
First posted
Mar 5, 2026
Start date
Feb 12, 2026 (estimated)
Primary completion
Feb 11, 2027 (estimated)
Completion
Feb 11, 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Gyeong Jo Byun, MD
Contact
byeongj@pusan.ac.kr
82-10-5663-1713

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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