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A Clinical Trial to Compare the Effects of Oral Tarooneh and Placebo on Patients' Pain after Lumbar surgery

Protocol summary

Summary
Objective: The goal of this study is to determine the effect of oral Tarooneh on post lumbar disc surgery pain and prevention of severe pain-related complications and reduction of treatment costs and hospitalization period. Design of the study: a Randomized (with the Block of size 4), double blind, controlled, single-centered, phase 2 trial. Study population: Patients with lumbar disc disease. Inclusion criteria: Having discopathy without fusion. Exclusion criteria: Unwillingness to attend the study. Sample size: 70. Intervention or interventions: After receiving an informed consent and filling a questionnaire, the pain (by VAS) and vital signs will be measured one hour before the first dose of pain killer. Then, Tarooneh will be delivered to the patients in intervention group, 5 cc, 6, 12 and 24 hours after surgery (3 times) in addition to the usual treatments. The control group will receive the placebo instead of Tarooneh. One hour after receiving each dose, the pain status using Visual Analog Scale (VAS) and vital signs will be evaluated. Main outcome variables: Primary outcome: Pain Secondary outcomes: Blood pressure, Pulse rate, Breathing rate, temperature.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017063034815N1
Registration date: 2017-09-27, 1396/07/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Zahra Shahsavari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
z.shahsavari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Arak University of Medical Sciences.
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial to Compare the Effects of Oral Tarooneh and Placebo on Patients' Pain after Lumbar surgery
Public title
The effect of Tarooneh on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age range 30 to 50 years; Having discopathy without fusion; Not fasting; Does not have a disease that increases or decreases pain; Do not breast-feed or be pregnant;Non-addiction;Specific underlying disease, such as heart disease;Tarooneh insensitivity. Exclusion criteria:Unwillingness to attend the study; Transfer to another department.
Age
From 30 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization method with four blocks will be used for randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Student Ethics Committee, Arak University of Medical Sciences, Arak, Iran
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Rah Ahan Street,
City
Arak
Postal code
3848176941
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.41

Health conditions studied

1

Description of health condition studied
lumbar pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
pain
Timepoint
One hour before the intervention and 7,13 and 25 hours after the intervention
Method of measurement
Visual Analog Scale(vas)

Secondary outcomes

1

Description
Blood pressure
Timepoint
One hour before the intervention and 7,13 and 25 hours after the intervention.
Method of measurement
Sphygmomanometer.

2

Description
Temperature
Timepoint
One hour before the intervention and 7,13 and 25 hours after the intervention
Method of measurement
Centimeter using a thermometer

3

Description
heart beat
Timepoint
One hour before the intervention and 7,13 and 25 hours after the intervention
Method of measurement
pulse/min using a Puls Oximeter

4

Description
Breathing
Timepoint
One hour before the intervention and 7,13 and 25 hours after the intervention
Method of measurement
respiratory rate/ min by viewing

Intervention groups

1

Description
Intervention group: Tarooneh, 5 mg, orally, 3 times a day at 6, 12 and 24 hours after surgery.
Category
Placebo

2

Description
Control group: Distilled water, 5 mg, orally, 3 times a day at 6, 12 and 24 hours after surgery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Zahra SHahsavari
Street address
Valiasr Hospital, Vali Asr Square, Arak, Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Bagheri
Street address
Arak University of Medical Sciences, Sardasht, Arak, Markazi, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra SHahsavari
Position
Student/MSc
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Arak, Markazi, Iran
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
www.ararkmu.ac.ir; z.shahsavari@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ahmad Reza Abedi
Position
Phd of nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak, Markazi, Iran
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
www.arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra SHahsavari
Position
Student/Masters
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak, Markazi, Iran
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
www.arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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