The aim of this double blind randomized clinical trial is to assess the effectiveness of preoperative oral Melatonin on post operative pain in patient undergoing elective disc surgery. After getting informed consent, eighty ASA1 patients who are candidate for elective one or two level discectomy, randomly allocate in four equal groups. Inclusion Criteria are net diagnosis with physical exam, CTscan, MRI; patient agreement and informed written consent; candidate of elective surgery; age 35 to 70 years. Exclusion criteria are Unwillingness of patient to continue the trial; emergency surgery; more than two level of disc; consumption of opium 24 hour before surgery; drug or alcohol abuse; any unusual complication during surgery.
The A group receives 3mg Melatonin, group B receives 5 mg Melatonin, , group C receives 10 mg Melatonin and group D receives Placebo one hour before surgery. Then pain intensity, nausea and vomiting, pruritus are assessed at 1, 6, 12, 24 hours postoperatively by VAS. Data will be analyzed with SPSS 22.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701304365N20
Registration date:2017-02-16, 1395/11/28
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-02-16, 1395/11/28
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative melatonin on pain intensity after lumbar disc surgery
Public title
Effect of melatonin on pain intensity after lumbar disc surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: net diagnosis with physical exam, CTscan, MRI; patient agreement and informed written consent; candidate of elective surgery; age 35 to 70 years.
Exclusion criteria: Unwillingness of patient to continue the trial; emergency surgery; more than two level of disc; consumption of opium 24 hour before surgery; drug or alcohol abuse; any unusual complication during surgery.
Age
From 35 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Moallem Square, Mazandaran University of Medical Sciences
City
sari
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
ir mazums rec 95 1821
Health conditions studied
1
Description of health condition studied
lumbar discopathy
ICD-10 code
G55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
Description
Pain after disc surgery
Timepoint
1, 6, 12, 24 hour after surgery
Method of measurement
VAS
Secondary outcomes
1
Description
Pruritus,Nausea and vomiting,Satisfaction of pain cotrol
Timepoint
1,6,12,24 hour after surgery
Method of measurement
VAS
Intervention groups
1
Description
Intervention A: Tablet Melatonin 3 mg, 1 hour before surgery
Category
Treatment - Drugs
2
Description
Intervention B: Tablet Melatonin 5 mg, 1 hour before surgery
Category
Treatment - Drugs
3
Description
Intervention C: Tablet Melatonin 10 mg, 1 hour before surgery
Category
Treatment - Drugs
4
Description
Control: Tablet Placebo, 1 hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD, CCMF, Associate Professor
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati, MD
Street address
Moallem Square, Mazandaran university of medical sciences, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Habibi, MD
Position
CAF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Imam Khomeini General Hospital, Amir St
City
Sari
Postal code
Phone
+98 11 3326 2679
Fax
Email
mrhahibi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Imam Khomeini General Hospital, Amir St
City
Sari
Postal code
Phone
+98 11 3326 2679
Fax
Email
gholipourafshin@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samira Sobhani, MD
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Imam Khomeini General Hospital, Amir St
City
Sari
Postal code
Phone
+98 11 3326 2679
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)