The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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 administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Treatments: Citric Acid; Fentanyl; Nalbuphine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.