The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery
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|ClinicalTrials.gov Identifier: NCT03296488|
Recruitment Status : Unknown
Verified September 2017 by Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was: Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Nalbuphine Sebacate Drug: Fentanyl Citrate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 17, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Nalbuphine Sebacate
receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery.
Drug: Nalbuphine Sebacate
intramuscular single dose of NALDEBAIN 24±12 hours before surgery.
Other Name: NALDEBAIN
Active Comparator: Fentanyl Citrate
receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
Drug: Fentanyl Citrate
Intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
Other Name: PCA with fentanyl
- 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.
- supplemental analgesics [ Time Frame: From post-OP to Day 6 ]The consumption of total amount (mg) of supplemental analgesics administered after surgery.
- Pain assessment (post-OP to Day 6) [ Time Frame: From post-OP to Day 6 ]Pain assessment calculated as the area under the curve of VAS pain intensity scores through end of surgery to Day 6
- Brief Pain Inventory [ Time Frame: pre-OP Day -1, post-OP Day 2 and Day 6 ]Pain intensity and interference of Brief Pain Inventory (BPI)
- Patient satisfaction [ Time Frame: On discharge Day, between post-OP Day 7 and Day 14 ]Patient satisfaction on a 5-point rating.
- Length of postoperative hospital stay [ Time Frame: From post-OP to Discharge Day, about 1 to 2 weeks ]Length of postoperative hospital stay.
- Adverse event [ Time Frame: From post-OP Day 1 to Discharge Day, about 1 to 2 weeks ]Incidence of treatment-emergent adverse event (TEAE)
- other abnormalities [ Time Frame: From Screening Day to Discharge Day, about 1 to 2 weeks ]Percentage of abnormal from baseline to final visit in vital signs, laboratory tests and injection site evaluations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296488
|Chung-Ho Memorial Hospital, Kaohsiung Medical University:||Recruiting|
|Kaohsiung, Taiwan, 807|
|Contact: Jaw-Yuan Wang, PhD +886-7-3121101 ext 5575 email@example.com|
|Contact: Tsung-Kun Chang, MD +886-7-3121101 ext 5575 firstname.lastname@example.org|
|Principal Investigator: Jaw-Yuan Wang, Ph.D.|
|Sub-Investigator: Tsung-Kun Chang, MD|
|Study Chair:||Jaw-Yuan Wang, PhD||Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University|