Protocol summary

Study aim
Efficacy of Pentoxifylline in pain assessment after Laminectomy surgery
Design
The clinical trial with the control group, with parallel, double-blind, randomized, phase-referred groups, on 72 patients.www.randomization.com site is used for randomization.
Settings and conduct
In 1401, 72 patients will be included in the study in Shah Vali hospita haspital, the study will be double-blind, and the Pain Assessor and patient will be unaware of the grouping of patients. To blind the patients, placebo and for blinding the evaluator, the group encoding will be used in the form of a and b. One hour before surgery, one hour and 24 hours after surgery, pain levels will be evaluated in both groups using VAS. The reported pain is compared between the two groups and then compared.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients who are candidates for Laminectomy surgery and are over 15 years old Non-entry requirements: Patients with alcohol or substance abuse, patients who smoked, pregnant mothers, those with liver disease, diabetes, immunodeficiency (the use of immunosuppressive drugs or chemotherapy), AIDS, acute bowel disease, cancer, Children under the age of 15 and people older than 75 who are getting information from them are difficult.
Intervention groups
Intervention group ": In this group, one capsule of pentoxylline supplied by Farabi Pharmaceutical Company is given to the patient one hour before laminectomy. "Control Group": In this group, one hour before laminectomy, a 400 mg capsule of pentoxylline whose contents are emptied and filled with starch is given to the patient.
Main outcome variables
The rate of pain based on the VAS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220526054991N1
Registration date: 2022-06-13, 1401/03/23
Registration timing: prospective

Last update: 2022-06-13, 1401/03/23
Update count: 0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Hamid Hobobati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 4556
Email address
hh1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative Pentoxifylline administration on postoperative pain inpatients undergoing Laminectomy
Public title
The effect of Pentoxifylline in the treatment of pain in patients undergoing Laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for Laminectomy surgery and are over 15 years old.
Exclusion criteria:
Smoker Patients who have alcohol or substance abuse liver disease, diabetes, immunodeficiency (use of immunosuppressive drugs or chemotherapy), AIDS, acute bowel disease, cancer, and dialysis patients. Pregnant Children under the age of 15 and people older than 75 who are getting information from them is hard.
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to two groups by simple randomization method they are divided. How to select people and place them in dual groups It will be random, so after confirming the necessary conditions for the direction of Entering the study selected patients consecutively, the first patient in The first group will put the second patient in the second group. And so on. Again, the groups will take each patient to the limit. The number of samples in the intervention and control groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs studied by a neurosurger who does not have participated in the scheme , is prepared and in closed envelopes with the patient's code written on it Envelopes are preserved in the neurosurgical ward one day before surgery ; Day of surgery;The day after surgery by neurosurgeve that type of medication and The group where the patient is located does not know it opens. Nurses Patients and pain assessors are also unaware of the type of drug and the patient group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University_ Yazd Branch
Street address
Islamic Azad University, Alam Square,Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.IAU.YAZD.REC.1400.062

Health conditions studied

1

Description of health condition studied
pain after Laminectomy
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
Severity of back pain
Timepoint
One hour before surgery, one hour after surgery and 24 hours after surgery
Method of measurement
Measurement of back pain based on Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group, one capsule of 400 mg pentoxylline product of Farabi Pharmaceutical Company will be given to the patient orally one hour before surgery, the number of tablets will be taken only once. And the possible complications will be monitored by attending the patient's bedside.
Category
Treatment - Drugs

2

Description
Control group: In this group, 36 eligible patients who are scheduled to undergo laminectomy and have been randomly assigned to this group will be given a 400 mg pentoxylline capsule of Farabi Company whose contents are empty and filled with starch, one hour before surgery will be given to the patient orally, the capsule will be prepared from Farabi Pharmaceutical Company. The number of times you take the pill will only be once. And the possible complications will be monitored by attending the patient's bedside.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shah Vali Hospital
Full name of responsible person
Hamid Hobobati
Street address
Shah Vali Hospital , Professor Hesari Street
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 1000
Fax
+98 35 3821 5034
Email
hh1358@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Mohammadreza Mortazavizadeh
Street address
Islamic Azad University, Alam Square,Shohadaye Gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Fax
+98 35 3821 5034
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hobobati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
No.2 ,Saadat Ave.,Razmandegan Town
City
Yazd
Province
Yazd
Postal code
8915134714
Phone
+98 35 3820 4556
Email
hh1358@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hobobati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
No.2 ,Saadat Ave.,Razmandegan Town
City
Yazd
Province
Yazd
Postal code
34714_89151
Phone
+98 35 3820 4556
Email
hh1358@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hanieh Alsadat Fatemifar
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Neurosurgery
Street address
No.2 ,Saadat Ave.,Razmandegan Town
City
Yazd
Province
Yazd
Postal code
8915134714
Phone
+98 35 3820 4556
Email
honeyfatemi97@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and results of the research
When the data will become available and for how long
After the final report (2023)
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Observing the author's right
From where data/document is obtainable
Call the inserted email and number.
What processes are involved for a request to access data/document
After submitting the request and reviewing it in the shortest possible time, they will be answered (one week)
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