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

July 14, 2020 updated by: Cathay General Hospital
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Cathay General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: 24 hours after surgery
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of supplemental analgesics
Time Frame: From Day 0 to Day 3
Sum of supplemental analgesics
From Day 0 to Day 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse event
Time Frame: From Day 0 to Day 3
Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)
From Day 0 to Day 3
Percentage of Patient satisfaction
Time Frame: Day 3
Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cathay General Hospital

Investigators

  • Principal Investigator: Sing-Ong Lee, MD, Cathay General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (ACTUAL)

October 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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