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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naldebain

Subjects will receive one dose of Naldebain before surgery.

Group Type EXPERIMENTAL

Naldebain

Intervention Type DRUG

150 mg Nalbuphine sebacate

Morphine

Subjects will receive morphine after surgery.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine

Interventions

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Naldebain

150 mg Nalbuphine sebacate

Intervention Type DRUG

Morphine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No