Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain; Opioid Side Effects
• Intervention / Treatment: Drug: group A; Drug: group B; Drug: group C

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Record the opioid dose changes 2 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
use of antiemetics	if the patient use of antiemetics during the hospitalization	2 days
use of antipruritics	if the patient use of antipruritics during the hospitalization	2 days

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Guan-Yu Chen, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (ACTUAL): October 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 20, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: nalbuphine dose
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: KMUHIRB-F(I)-20190070

Drug and device information, study documents

• 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