Protocol summary
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Study aim
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Determining the Effect of preoperative Melatonin on the Severity of Postoperative pain in Patients undergoing Elective Discectomy Surgery
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Design
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This study is a Randomized, double Blind controlled Clinical Trial with the Aim of Determining the Effect of preoperative Melatonin on the Severity of Postoperative pain in Patients undergoing Elective Discectomy Surgery. After Obtaining informed Consent, 80 Patients undergoing Surgical Disks, one or two Lumbar spaces and Anesthesia Classes 1 and 2 are divided into four Groups using Random Allocation Method.
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Settings and conduct
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The site of the study was in Imam Khomeini Hospital in Sari and was controlled by blind randomized random allocation method and divided into four Groups. Clinical Blind Attendants and Caregivers and Researchers and Analysts were blinded.
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Participants/Inclusion and exclusion criteria
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Entry Criteria: Confirmation of Diagnosis by Physical Exam, CT Scan and MRI; Patient's Willingness to participate in the Study and Obtaining informed consent; The candidate for Non-Emergency Discectomy Surgery; Age of 35-70 years
Exit Criteria: The patient's unwillingness at any time to continue to participate in the Study; Emergency Discomtious Surgery; Involvement of more than two Lumbar Discs; use of opiate medication up to 24 hours before intervention; Alcohol orDrug abuse; incidence of each Type of an uncommon side Effect during Surgery
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Intervention groups
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Intervention group A: One Tablet of 3 mg Melatonin
Intervention group B: One Tablet of 5 mg Melatonin
Intervention group C: One Tablet of 10 mg Melatonin
Intervention group D: One Tablet of plasebo tablets is given to Patients one hour before Surgery.
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Main outcome variables
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Painless; Reduction of Nausea and Vomiting; Itching; Satisfaction
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201701304365N20
Registration date:
2017-02-16, 1395/11/28
Registration timing:
prospective
Last update:
2018-01-20, 1396/10/30
Update count:
1
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Registration date
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2017-02-16, 1395/11/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research of Mazandaran University of Medical Sciences
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Expected recruitment start date
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2017-04-16, 1396/01/27
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Expected recruitment end date
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2017-10-25, 1396/08/03
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Actual recruitment start date
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2017-04-16, 1396/01/27
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Actual recruitment end date
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2017-10-25, 1396/08/03
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Trial completion date
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empty
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Scientific title
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Effect of preoperative melatonin on pain intensity after lumbar disc surgery
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Public title
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Effect of melatonin on pain intensity after lumbar disc surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmation of the diagnosis using physical examination, computed tomography (CT) scan and magnetic resonance imaging (MRI)
patient agreement and informed written consent
candidate of elective discectomy surgery
age 35 to 70 years
Exclusion criteria:
consumption of opium 24 hour before surgery
drug or alcohol abuse
any unusual complication during surgery
Patients' unwillingness at any time to continue participation in this study
emergency discectomy surgery
involvement of more than two lumbar discs
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Age
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From 35 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
79
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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table of random numbers
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, participants, care providers, Investigator and Outcome assessor are blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-04-10, 1395/01/22
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Ethics committee reference number
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ir mazums rec 95 1821
Health conditions studied
1
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Description of health condition studied
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lumbar discopathy
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ICD-10 code
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G55.1
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ICD-10 code description
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Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
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Description
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Pain after disc surgery
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Timepoint
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1, 6, 12, 24 hour after surgery
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Method of measurement
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VAS
Secondary outcomes
1
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Description
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Pruritus,Nausea and vomiting,Satisfaction of pain cotrol
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Timepoint
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1,6,12,24 hour after surgery
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Method of measurement
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VAS
Intervention groups
1
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Description
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Intervention A: Tablet Melatonin 3 mg, 1 hour before surgery
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Category
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Treatment - Drugs
2
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Description
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Intervention B: Tablet Melatonin 5 mg, 1 hour before surgery
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Category
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Treatment - Drugs
3
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Description
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Intervention C: Tablet Melatonin 10 mg, 1 hour before surgery
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Category
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Treatment - Drugs
4
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Description
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Control: Tablet Placebo, 1 hour before surgery
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sari University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The Researcher does not currently see the Need for Data sharing in this Study.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available