Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

Pain, Postoperative Clinical Trial

Official title:

Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713216
• Other study ID #: 402
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2020
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

Description:

This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Male or female with 20 years old or older.

2. Scheduled to electively undergo laparoscopic cholecystectomy.

3. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Not willing to adhere to the study visit schedule and complete all study assessments.

2. History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.

3. Any clinically significant condition that may interfere with study assessments or compliance.

4. Pregnant or breastfeeding.

5. Medical history may cause abnormal intracranial pressure.

6. History of dependency, addiction, and withdrawal for narcotic drugs.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Naldebain
150 mg Nalbuphine sebacate
• Morphine
Morphine

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse event	Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)	From Day 0 to Day 3
Other	Percentage of Patient satisfaction	Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.	Day 3
Primary	Postoperative pain score	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	24 hours after surgery
Secondary	Consumption of supplemental analgesics	Sum of supplemental analgesics	From Day 0 to Day 3