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Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03713216
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cathay General Hospital

Brief Summary:
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Naldebain Drug: Morphine Phase 4

Detailed Description:
This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naldebain
Subjects will receive one dose of Naldebain before surgery.
Drug: Naldebain
150 mg Nalbuphine sebacate

Active Comparator: Morphine
Subjects will receive morphine after surgery.
Drug: Morphine
Morphine




Primary Outcome Measures :
  1. Postoperative pain score [ Time Frame: 24 hours after surgery ]
    Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)


Secondary Outcome Measures :
  1. Consumption of supplemental analgesics [ Time Frame: From Day 0 to Day 3 ]
    Sum of supplemental analgesics


Other Outcome Measures:
  1. Incidence of adverse event [ Time Frame: From Day 0 to Day 3 ]
    Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)

  2. Percentage of Patient satisfaction [ Time Frame: Day 3 ]
    Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female with 20 years old or older.
  2. Scheduled to electively undergo laparoscopic cholecystectomy.
  3. Ability and willingness to provide informed consent.

Exclusion Criteria:

  1. Not willing to adhere to the study visit schedule and complete all study assessments.
  2. History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
  3. Any clinically significant condition that may interfere with study assessments or compliance.
  4. Pregnant or breastfeeding.
  5. Medical history may cause abnormal intracranial pressure.
  6. History of dependency, addiction, and withdrawal for narcotic drugs.

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): NCT03713216


Locations
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Taiwan
Cathay General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Cathay General Hospital
Investigators
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Principal Investigator: Sing-Ong Lee, MD Cathay General Hospital

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Responsible Party: Cathay General Hospital
ClinicalTrials.gov Identifier: NCT03713216     History of Changes
Other Study ID Numbers: 402
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents