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Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

Primary Purpose

Post Operative Pain, Opioid Side Effects

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
group A
group B
group C
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring nalbuphine dose

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patient accept laparoscopic cholecystectomy
  • age:20-80 years old

Exclusion Criteria:

  • nalbuphine allergy
  • 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

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

group A

Group B

Group C

Arm Description

mutonpain 0.05 mg/kg

mutonpain 0.1 mg/kg

mutonpain 0.2 mg/kg

Outcomes

Primary Outcome Measures

Numerical Rating Pain Scale
The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The investors will measure the pain score at rest state and upon movement state at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours.
consumption of nalbuphine
The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.

Secondary Outcome Measures

nausea
we will go to bed side and have an self-report episode of nausea at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
vomiting
we will go to bed side and have an self-report episode of vomiting at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
satisfactory score by net promoter score
The net promoter score is a subjective measure in which individuals rate their satisfactory on an ten-point numerical scale. The scale is composed of 1 to 10. We will measure the net promoter score at the end of the study
use of rescue pain medications
if the patient use other pain medication on request of poor pain control or poor tolerant of the side effects of nalbuphine

Full Information

First Posted
October 16, 2019
Last Updated
October 20, 2019
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04135534
Brief Title
Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
Official Title
Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. The investigators will randomize patients into three groups to compare the analgesia effects and side effects.
Detailed Description
Nalbuphine is a FDA approved noncontrolled drug of opioid. And it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Opioid Side Effects
Keywords
nalbuphine dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
mutonpain 0.05 mg/kg
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
mutonpain 0.1 mg/kg
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
mutonpain 0.2 mg/kg
Intervention Type
Drug
Intervention Name(s)
group A
Intervention Description
mutonpain 0.05 mg/kg
Intervention Type
Drug
Intervention Name(s)
group B
Intervention Description
mutonpain 0.1 mg/kg
Intervention Type
Drug
Intervention Name(s)
group C
Intervention Description
mutonpain 0.2 mg/kg
Primary Outcome Measure Information:
Title
Numerical Rating Pain Scale
Description
The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The investors will measure the pain score at rest state and upon movement state at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours.
Time Frame
numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Title
consumption of nalbuphine
Description
The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.
Time Frame
Record the opioid dose changes 2 days.
Secondary Outcome Measure Information:
Title
nausea
Description
we will go to bed side and have an self-report episode of nausea at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
Time Frame
the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Title
vomiting
Description
we will go to bed side and have an self-report episode of vomiting at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
Time Frame
the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Title
satisfactory score by net promoter score
Description
The net promoter score is a subjective measure in which individuals rate their satisfactory on an ten-point numerical scale. The scale is composed of 1 to 10. We will measure the net promoter score at the end of the study
Time Frame
2 days
Title
use of rescue pain medications
Description
if the patient use other pain medication on request of poor pain control or poor tolerant of the side effects of nalbuphine
Time Frame
record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Other Pre-specified Outcome Measures:
Title
use of antiemetics
Description
if the patient use of antiemetics during the hospitalization
Time Frame
2 days
Title
use of antipruritics
Description
if the patient use of antipruritics during the hospitalization
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient accept laparoscopic cholecystectomy age:20-80 years old Exclusion Criteria: nalbuphine allergy 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guan-Yu Chen, MD
Phone
88673121101
Ext
7035
Email
kindtaco@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-I Cheng, PhD
Phone
88673121101
Ext
7035
Email
Kuaich@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guan-Yu Chen, MD
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guan-Yu Chen, MD
Phone
88673121101
Ext
7035
Email
kindtaco@gmail.com

12. IPD Sharing Statement

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Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

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