Status:
UNKNOWN
NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
Lead Sponsor:
China Medical University Hospital
Conditions:
Postoperative Pain
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. It was approv...
Detailed Description
This is an open-labeled, randomized clinical trial. After ICFs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. And then, on Day -1, eligib...
Eligibility Criteria
Inclusion
- Men and Women between 20 and 80 years of age
- History of laparoscopic surgery
- American Society of Anesthesiology Physical Class 1-3
- Ability and willingness to provide informed consent
Exclusion
- History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen
- Chronic preoperative opioid use
- Severe comorbidity which is able to interfere pain assessment
- Ostomy surgery of intestine within the past 8 weeks
- Pregnant or breastfeeding
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03854851
Start Date
March 1 2019
End Date
October 31 2019
Last Update
February 26 2019
Active Locations (1)
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1
China Medical University & Hospital
Taichung, Taiwan, 404