Post Operative PainNCT04135534
Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
A study testing group A, group B and group C in people with Post Operative Pain and Opioid Side Effects, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Opioid Side Effects
- What is being tested?
- group A, group B and group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient accept laparoscopic cholecystectomy
- age:20-80 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Guan-Yu Chen, MD, 88673121101 ext. 7035, kindtaco@gmail.com
About this study
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.
Read the 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.
- Conditions
- Post Operative Pain, Opioid Side Effects
- Being tested
- group A, group B, group C
- Keywords
- nalbuphine dose
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group ADrug
mutonpain 0.05 mg/kg
group BDrug
mutonpain 0.1 mg/kg
group CDrug
mutonpain 0.2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | mutonpain 0.05 mg/kg Receives: Drug: group A |
| Group B | Active comparator | mutonpain 0.1 mg/kg Receives: Drug: group B |
| Group C | Active comparator | mutonpain 0.2 mg/kg Receives: Drug: group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: numerical rating pain scale change 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.
Measured: Record the opioid dose changes 2 days.
Secondary outcomes (4)
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
Measured: the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
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
Measured: the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
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
Measured: 2 days
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
Measured: record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KMUHIRB-F(I)-20190070, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Guan-Yu Chen, MD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135534
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190070
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04135534
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190070
- Conditions
- Post Operative Pain, Opioid Side Effects
- Keywords
- nalbuphine dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: group Amutonpain 0.05 mg/kg |
| Group B | Active comparator | Drug: group Bmutonpain 0.1 mg/kg |
| Group C | Active comparator | Drug: group Cmutonpain 0.2 mg/kg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient accept laparoscopic cholecystectomy
- age:20-80 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group Amutonpain 0.05 mg/kg | Drug | group A |
| group Bmutonpain 0.1 mg/kg | Drug | Group B |
| group Cmutonpain 0.2 mg/kg | Drug | Group C |
Primary outcome
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.
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.
4 secondary outcomes
nausea
Time frame: the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
vomiting
Time frame: the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
satisfactory score by net promoter score
Time frame: 2 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guan-Yu Chen, MD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group A, group B and group C in people with Post Operative Pain and Opioid Side Effects, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guan-Yu Chen, MD (88673121101 ext. 7035, kindtaco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.