Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Post Operative Pain; Opioid Side Effects
• Interventions: Drug: group A; Drug: group B; Drug: group C

• Registration Number: NCT04135534
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-20
• Last Update Submitted: 2019-10-20
• Study First Posted: 2019-10-22
• Last Update Posted: 2019-10-22
• Study Start: 2019-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	group A	mutonpain 0.05 mg/kg
Group B	group B	mutonpain 0.1 mg/kg
Group C	group C	mutonpain 0.2 mg/kg

Primary Outcome Measures

Name	Time	Method
Numerical Rating Pain Scale	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	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

Name	Time	Method
use of rescue pain medications	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
nausea	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
vomiting	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
satisfactory score by net promoter score	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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan