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NCT Number: NCT03713216

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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cathay General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Naldebain

Drug

150 mg Nalbuphine sebacate

Morphine

Drug

Morphine

Primary outcomes

  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 outcomes

  1. Consumption of supplemental analgesics

    Time frame: From Day 0 to Day 3

    Sum of supplemental analgesics

Other outcomes

  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'.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cathay General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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