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A Randomized, Single-Blind Prospective Study on the Efficacy of Surgical Site Pain Control Agents in Patients Undergoing General Gynecologic Surgery Using One-Port Laparoscopy

Randomized Blinded Prospective Observational Study on the Utility of Local Pain Control in Surgical Site Pain Management in General Gynecologic Surgery Patients Using Single-Injection Minimum-Chip Technique

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0010224
Enrollment
420
Registered
2025-02-21
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This study aims to investigate the difference in pain control when a thermosensitive pain control gel (WELPASS), which is slowly released over 72 hours when injected directly at the s

Sponsors

The Catholic University of Korea, Incheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who understand and provide written consent to participate in this study, which involves treatment as part of an experimental group receiving both injectable pain medication and a thermosensitive gel applied to the surgical site under a blinded randomized allocation. Additionally, patients must be able to communicate effectively about their pain.

Exclusion criteria

Exclusion criteria: 1. Patients unable to communicate verbally or non-verbally. 2. Patients with pathological pain syndromes, such as Complex Regional Pain Syndrome (CRPS). 3. Patients with a history of treatment at a pain management clinic. 4. Patients with adverse reactions to injectable pain medications. 5. Patients who do not consent to the use of IV PCA. 6. Patients with hypersensitivity to components of the thermosensitive gel, such as Poloxamer or Sodium Alginate. 7. Patients with lymphatic fluid disorders, coagulation disorders, or severe liver or kidney diseases. 8. Pregnant women. 9. Vulnerable subjects, including students, employees, or soldiers who may face disadvantages from superiors in the hierarchy, individuals with cognitive impairments (including those medically incapable of providing consent), patients with incurable or terminal diseases, foreigners, or patients in emergency situations.

Design outcomes

Primary

MeasureTime frame
Efficacy of WELPASS in Pain Control

Secondary

MeasureTime frame
Safety of WELPASS

Countries

Korea, Republic of

Contacts

Public Contactbowon kim

The Catholic University of Korea, Incheon St. Mary's Hospital

107qhdnjs@naver.com+82-32-280-6523

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026