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Comparison of the effectiveness of local analgesic injection pump devices and local topical gel-type analgesic agents for postoperative pain control in patients undergoing bariatric metabolic surgery: A randomized controlled trial

Comparison of the effectiveness of local analgesic injection pump devices and local topical gel-type analgesic agents for postoperative pain control in patients undergoing bariatric metabolic surgery: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009540
Enrollment
48
Registered
2024-06-14
Start date
2023-07-24
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

None listed

Interventions

Drug, Medical Device : Both the experimental and control groups apply a local analgesic-anesthetic once during wound closure after bariatric surgery. The experimental group, known as the Welpass group

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study enrolled participants who satisfied the National Health Insurance criteria for bariatric surgery, which necessitates a body mass index (BMI) of =35 kg/m2 or a BMI of =30 kg/m2 with associated obesity-related complications such as hypertension, hyperlipidemia, diabetes, fatty liver and polycystic ovary syndrome. And individuals aged 19 years or older who voluntarily consented to participate in the study were included.

Exclusion criteria

Exclusion criteria: The exclusion criteria included: 1) Patients who were currently receiving, or had previously received, any investigational products, or those with medical conditions that could affect the safety and efficacy evaluation of this medical device; 2) Patients with known hypersensitivity to ropivacaine or other amide-type local anesthetics; 3) Patients experiencing severe bleeding or shock; 4) Patients with inflammation at or around the site of injection; 5) Patients suffering from sepsis; 6) Patients requiring intravenous partial anesthesia; 7) Patients who had participated in another clinical study within the past 30 days; 8) Patients considered unsuitable by the investigator for various reasons, such as lack of cooperation; and 9) Patients with contraindications to using ketorolac.

Design outcomes

Primary

MeasureTime frame
Total usage of Ketorolac

Secondary

MeasureTime frame
Postoperative pain intensity (Numeral Rating Scale)

Countries

Korea, Republic of

Contacts

Public ContactMira Yoo

Seoul National University Bundang Hospital

mirayoo289@gmail.com+82-31-787-7099

Outcome results

None listed

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