Status:
UNKNOWN
The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
Pain, Postoperative
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by a...
Detailed Description
Screening (Days -30 to -1) (All Study Subjects) The nature of the study, as well as the potential risks and benefits associated with study participation, will be fully explained to all potential subj...
Eligibility Criteria
Inclusion
- Male or female who is among 20 to 80 years of age at screening.
- Scheduled to electively undergo open-laparotomy.
- American Society of Anesthesiology Physical Class 1-3.
- Ability and willingness to provide informed consent
Exclusion
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2.
- History of previous open-laparotomy.
- Surgery with major complication, or need blood transfusion.
- History of hypersensitivity or adverse reaction to local anesthetics, opioid, or any ingredient of the medications administered in this study.
- Severe comorbidity.
- Chronic preoperative opioid consumption.
- Pregnant or breastfeeding.
- Inability to use the PCA device.
Key Trial Info
Start Date :
August 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03296488
Start Date
August 17 2017
End Date
December 31 2018
Last Update
September 28 2017
Active Locations (1)
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1
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, Taiwan, 807