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

• Sponsor: Cathay General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03713216
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 18
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Naldebain; Drug: Morphine	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naldebain Subjects will receive one dose of Naldebain before surgery.	Drug: Naldebain; 150 mg Nalbuphine sebacate
Active Comparator: Morphine Subjects will receive morphine after surgery.	Drug: Morphine; Morphine

Outcome Measures

Primary Outcome Measures

1. Postoperative pain score [24 hours after surgery]

   Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

1. Consumption of supplemental analgesics [From Day 0 to Day 3]

   Sum of supplemental analgesics

Other Outcome Measures

1. Incidence of adverse event [From Day 0 to Day 3]

   Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)

2. Percentage of Patient satisfaction [Day 3]

   Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cathay General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Cathay General Hospital

Investigators

• Principal Investigator: Sing-Ong Lee, MD, Cathay General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cathay General Hospital
• ClinicalTrials.gov Identifier: NCT03713216
• Other Study ID Numbers: 402
• First Posted: Oct 19, 2018
• Last Update Posted: Jul 16, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Morphine

Study Results

No Results Posted as of Jul 16, 2020