Clinical trial NCT04135534: Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
Official title: Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Opioid Side Effects
Keywords: nalbuphine dose
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical Rating Pain Scale
timeFrame: numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
measure: consumption of nalbuphine
timeFrame: Record the opioid dose changes 2 days.
Secondary outcomes:
measure: nausea
timeFrame: the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
measure: vomiting
timeFrame: the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
measure: satisfactory score by net promoter score
timeFrame: 2 days
measure: use of rescue pain medications
timeFrame: record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Other outcomes:
measure: use of antiemetics
timeFrame: 2 days
measure: use of antipruritics
timeFrame: 2 days
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Guan-Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: