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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
Sponsor:
Information provided by (Responsible Party):
Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Nalbuphine Sebacate Drug: Fentanyl Citrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. supplemental analgesics [ Time Frame: From post-OP to Day 6 ]
    The consumption of total amount (mg) of supplemental analgesics administered after surgery.

  2. 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

  3. 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)

  4. Patient satisfaction [ Time Frame: On discharge Day, between post-OP Day 7 and Day 14 ]
    Patient satisfaction on a 5-point rating.

  5. Length of postoperative hospital stay [ Time Frame: From post-OP to Discharge Day, about 1 to 2 weeks ]
    Length of postoperative hospital stay.


Other Outcome Measures:
  1. Adverse event [ Time Frame: From post-OP Day 1 to Discharge Day, about 1 to 2 weeks ]
    Incidence of treatment-emergent adverse event (TEAE)

  2. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University: Recruiting
Kaohsiung, Taiwan, 807
Contact: Jaw-Yuan Wang, PhD    +886-7-3121101 ext 5575    cy614112@ms14.hinet.net   
Contact: Tsung-Kun Chang, MD    +886-7-3121101 ext 5575    tsungkunchang@gmail.com   
Principal Investigator: Jaw-Yuan Wang, Ph.D.         
Sub-Investigator: Tsung-Kun Chang, MD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: Jaw-Yuan Wang, PhD Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaw-Yuan Wang, MD, PhD, Professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03296488    
Other Study ID Numbers: KMUHIRB-F(I)-20170089
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital:
post-laparotomy wound pain
NALDEBAIN (150 mg Nalbuphine Sebacate)
PCA (patient-control-ed alagesia)
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics