Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
NCT ID: NCT04135534
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-11-01
2020-12-01
Brief Summary
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Detailed Description
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However, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. If the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid.
The investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. If the pain or side effects of opioid were intolerable, the investigators will change pain medications into NSAIDs or other adequate medications to comfort the patient.
The primary outcome were numerical rating pain score and consumption of nalbuphine. The secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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group A
mutonpain 0.05 mg/kg
group A
mutonpain 0.05 mg/kg
Group B
mutonpain 0.1 mg/kg
group B
mutonpain 0.1 mg/kg
Group C
mutonpain 0.2 mg/kg
group C
mutonpain 0.2 mg/kg
Interventions
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group A
mutonpain 0.05 mg/kg
group B
mutonpain 0.1 mg/kg
group C
mutonpain 0.2 mg/kg
Eligibility Criteria
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Inclusion Criteria
* age:20-80 years old
Exclusion Criteria
* chronic pain
* active liver disease that would affect metabolization of nalbuphine
* patient who had regular pain medications
* patient who could not cooperate to the evaluation of the survey
* dementia or other psychiatric disease
20 Years
80 Years
ALL
Yes
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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KMUHIRB-F(I)-20190070
Principal Investigator
Principal Investigators
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Guan-Yu Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KMUHIRB-F(I)-20190070
Identifier Type: -
Identifier Source: org_study_id
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