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Find the Adequate Dose of Nalbuphine for 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135534
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
KMUHIRB-F(I)-20190070, Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Opioid Side Effects Drug: group A Drug: group B Drug: group C Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A
mutonpain 0.05 mg/kg
Drug: group A
mutonpain 0.05 mg/kg

Active Comparator: Group B
mutonpain 0.1 mg/kg
Drug: group B
mutonpain 0.1 mg/kg

Active Comparator: Group C
mutonpain 0.2 mg/kg
Drug: group C
mutonpain 0.2 mg/kg




Primary Outcome Measures :
  1. Numerical Rating Pain Scale [ Time Frame: numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours ]
    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.

  2. consumption of nalbuphine [ Time Frame: Record the opioid dose changes 2 days. ]
    The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.


Secondary Outcome Measures :
  1. nausea [ Time Frame: the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours ]
    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

  2. vomiting [ Time Frame: the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours ]
    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

  3. satisfactory score by net promoter score [ Time Frame: 2 days ]
    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

  4. use of rescue pain medications [ Time Frame: record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours ]
    if the patient use other pain medication on request of poor pain control or poor tolerant of the side effects of nalbuphine


Other Outcome Measures:
  1. use of antiemetics [ Time Frame: 2 days ]
    if the patient use of antiemetics during the hospitalization

  2. use of antipruritics [ Time Frame: 2 days ]
    if the patient use of antipruritics during the hospitalization



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04135534


Contacts
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Contact: Guan-Yu Chen, MD 88673121101 ext 7035 kindtaco@gmail.com
Contact: Kuang-I Cheng, PhD 88673121101 ext 7035 Kuaich@gmail.com

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Contact: Guan-Yu Chen, MD    88673121101 ext 7035    kindtaco@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Guan-Yu Chen, MD Kaohsiung Medical University Chung-Ho Memorial Hospital
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Responsible Party: KMUHIRB-F(I)-20190070, Principal Investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04135534    
Other Study ID Numbers: KMUHIRB-F(I)-20190070
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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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
Keywords provided by KMUHIRB-F(I)-20190070, Kaohsiung Medical University Chung-Ho Memorial Hospital:
nalbuphine dose
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms