Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

Kaohsiung Medical University

Status: Unknown

Conditions: Opioid Side Effects; Post Operative Pain

Treatments: Drug: group A; Drug: group C; Drug: group B

Study type: Interventional

Funder types: Other

Identifiers

NCT04135534

KMUHIRB-F(I)-20190070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

group A

Active Comparator group

Description:

mutonpain 0.05 mg/kg

Treatment:

Drug: group A

Group B

Active Comparator group

Description:

mutonpain 0.1 mg/kg

Treatment:

Drug: group B

Group C

Active Comparator group

Description:

mutonpain 0.2 mg/kg

Treatment:

Drug: group C