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A single-center randomized, open-label, prospective study to evaluate efficacy and safety of DDK(Drug delivery kit, Welpass) for pain relief after gynecologic laparotomy surgery

A single-center randomized, open-label, prospective study to evaluate efficacy and safety of DDK(Drug delivery kit, Welpass) for pain relief after gynecologic laparotomy surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008852
Enrollment
110
Registered
2023-10-10
Start date
2023-10-02
Completion date
Unknown
Last updated
2023-10-16

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 : Patients undergoing open surgery for benign gynecological diseases are assigned to the test group and control group in a 1:1 ratio. PCA is applied with the same protocol to both the t

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Those who signed and sealed the clinical trial subject’s written consent to participate in the trial 2) Those who are over 18 years of age but under 80 years of age 3) Patients scheduled for open surgery for benign gynecological diseases using a transverse abdominal incision (Pfannenstiel) 4) Adequate hematological function, liver function, and renal function confirmed in preoperative examination 5) Patients scheduled to use a self-administered pain control device (PCA)

Exclusion criteria

Exclusion criteria: 1) Patients with a history of hypersensitivity to Ropivacaine or other amide-based local anesthetics 2) Patients with or history of hypersensitivity to fentanyl, its components, or other opioid drugs 3) Patients suffering from massive bleeding or shock 4) Patients with confirmed active (excluding asymptomatic urinary tract infection) or uncontrolled systemic infection 5) Patients who have continuously taken narcotic analgesics within 4 weeks before registration 6) Underweight (BMI 18.5 or less) or severe obesity (BMI 30 or more) 7) Currently have severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, or metabolic disease) 8) If you have high blood pressure that cannot be controlled with appropriate medication 9) Patients who have a thrombotic disorder or are receiving antithrombotic therapy 10) Patients who are pregnant or breastfeeding 11) Patients who participated in another clinical trial within 30 days before participating in the trial

Design outcomes

Primary

MeasureTime frame
Dose of fentanyl through PCA

Secondary

MeasureTime frame
Dose of rescue medication

Countries

Korea, Republic of

Contacts

Public ContactSo Hyun Nam

Asan Medical Center

gynamsh@gmail.com+82-2-3010-0869

Outcome results

None listed

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