Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

NCT04135534 | Unknown

• 1 other identifier: KMUHIRB-F(I)-20190070
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Opioid Side Effects

Keywords

nalbuphine dose

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• nausea

  the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours

• vomiting

  the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours

• satisfactory score by net promoter score

  2 days

• use of rescue pain medications

  record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours

Other Outcomes (2)

• use of antiemetics

  2 days

• use of antipruritics

  2 days

Study Arms (3)

group A

ACTIVE COMPARATOR

mutonpain 0.05 mg/kg

Drug: group A

Group B

ACTIVE COMPARATOR

mutonpain 0.1 mg/kg

Drug: group B

Group C

ACTIVE COMPARATOR

mutonpain 0.2 mg/kg

Drug: group C

Interventions

group A DRUG

mutonpain 0.05 mg/kg

group A

group B DRUG

mutonpain 0.1 mg/kg

Group B

group C DRUG

mutonpain 0.2 mg/kg

Group C

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient accept laparoscopic cholecystectomy
• age:20-80 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Guan-Yu Chen, MD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guan-Yu Chen, MD

CONTACT

88673121101; kindtaco@gmail.com

Kuang-I Cheng, PhD

CONTACT

88673121101; Kuaich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 22, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

TW (1)