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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT03417193 |
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Date of registration:
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16/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Opioid Free Anesthesia and Major Spine Surgery
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Scientific title:
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Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial |
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Date of first enrolment:
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January 29, 2018 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03417193 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Hanane MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lebanese American University/ LAU Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age group: 18-80 years old
- American Society of Anesthesiologists (ASA )class I, II and III
- Elective spine posterior instrumentation surgery of at least two levels.
Exclusion Criteria:
- Renal, hepatic or cardiac insufficiency.
- Alcohol or drug abuse.
- Psychiatric disease.
- Allergy or contraindication to any of the study drugs.
- Inability to comprehend pain assessment or inability to use a Patient Controlled
Analgesia (PCA) device.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Opioid Use
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Postoperative Pain
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Spine Disease
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Intervention(s)
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Drug: opioid free Anesthesia vs Opioid based Anesthesia
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Primary Outcome(s)
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Postoperative morphine consumption
[Time Frame: 48 hours]
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Secondary Outcome(s)
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Postoperative morphine Side effects: Sedation score .
[Time Frame: 48 hours post operative.]
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Postoperative morphine Side effects:Respiratory depression
[Time Frame: 48 hours]
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Postoperative pain score
[Time Frame: 48 hours post operative.]
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Postoperative morphine Side effects: Itching
[Time Frame: 48 hours]
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Postoperative morphine Side effects: Nausea vomiting
[Time Frame: 48 hours]
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Secondary ID(s)
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LAUMCRH.HB1.11/Jan/2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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