A Randomized Controlled Trial to Compare the Efficacy and Safety of NALDEBAIN With Intravenous Patient-Controlled Analgesia With Fentanyl for the Treatment of Post-Laparotomy Surgery
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- pain assessment (post-OP 48 hours)
Study Overview
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 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.
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 subjects. The following will then be obtained:
- Informed consent.
- Demographic information, including sex, age, BMI and type of surgery.
- Vital signs, including temperature, respiratory rate, blood pressure and heart rate.
- Medical history, including medication use and history of allergy.
- Physical examination.
- Laboratory testing, including hematological and biochemical tests, and urinalysis.
- ECG and X-ray.
Study Day -1 (All Eligible Subjects)
- Eligible subjects will be required to check into the clinical site before surgery (Day -1). The following procedures will be performed upon check-in:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Ability and willingness to provide informed consent
Exclusion Criteria
- •Body mass index less than 18 kg/m2 or greater than 30 kg/m
- •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.
Arms & Interventions
Nalbuphine Sebacate
receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery.
Intervention: Nalbuphine Sebacate (Drug)
Fentanyl Citrate
receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
Intervention: Fentanyl Citrate (Drug)
Outcomes
Primary Outcomes
pain assessment (post-OP 48 hours)
Time Frame: During post-OP 48 hours
Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery.
Secondary Outcomes
- Patient satisfaction(On discharge Day, between post-OP Day 7 and Day 14)
- Length of postoperative hospital stay(From post-OP to Discharge Day, about 1 to 2 weeks)
- Brief Pain Inventory(pre-OP Day -1, post-OP Day 2 and Day 6)
- Pain assessment (post-OP to Day 6)(From post-OP to Day 6)
- supplemental analgesics(From post-OP to Day 6)
Investigators
Jaw-Yuan Wang, MD, PhD
Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital