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Comparison the effect of preoperative use of oral gabapentin and pregabalin on spinal anesthesia characteristics and side effects

Protocol summary

Study aim
Determination of the effect of preoperative oral gabapentin and pregabalin on the characteristics and complications of spinal anesthesia
Design
This study is a clinical trial with parallel groups, randomized, phase one on 72 patients. For randomization in this study, permuted block randomization is performed with hexagonal blocks of letters A, B and C and two each (15 blocks) , each of them will be labeled by codes 1 to 15 and then using the table of random numbers numbers 1 to 15 will be selected and finally a sequence of letters A, B and C will be created.
Settings and conduct
This study is a double-blind clinical trial in which the clinical caregiver and participants were kept blind. The study was performed at Shahid Beheshti Hospital in Kashan in 2018-2019.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 18-70 years with ASA CLASS1-2 who undergo orthopedic or urological elective surgery below the T10 level under spinal anesthesia and their surgery time is less than 2 hours. Exclusion criteria: weight less than 40 kg, hypersensitivity to pregabalin, allergy to gabapentin or bupivacaine, localized sepsis at the injection site, dissatisfaction with spinal anesthesia
Intervention groups
Intervention group 1: receive 300 mg of oral gabapentin, Intervention group 2: receive 150 mg of oral pregabalin. Control group: receive an oral placebo (with the same drug form, appearance, and color similar to gabapentin and pregabalin containing the ineffective drug) 2 hours before surgery.
Main outcome variables
Time of onset of sensory block, duration of anesthesia, postoperative nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200918048748N1
Registration date: 2020-11-02, 1399/08/12
Registration timing: retrospective

Last update: 2020-11-02, 1399/08/12
Update count: 0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Nilofar barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
n.barzegar87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-24, 1398/04/03
Expected recruitment end date
2019-11-07, 1398/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of preoperative use of oral gabapentin and pregabalin on spinal anesthesia characteristics and side effects
Public title
Comparison of the effect of gabapentin and oral pregabalin on spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-70 years ASA class 1-2 undergoing orthopedic elective surgery with spinal anesthesia below the T10 level Duration of surgery less than 2 hours
Exclusion criteria:
Weight less than 40 kg Hypersensitivity to pregabalin Hypersensitivity to the drug gabapentin Allergy to bupivacaine Localized sepsis at the injection site of the spinal needle Pregnancy and lactation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is done as permuted block randomization with hexagonal blocks of letters A, B and C and two of each (15 blocks), each of them will be labeled by codes 1 to 15 and then using the table of random numbers numbers 1 to 15 will be selected and finally a sequence of letters A, B and C will be created. The letters represent each of the study groups and after entering the study, patients receive one of the medications prescribed by the nurse. The drugs are prepared in the same containers and in the form of capsules with the same and uniform pustules. The person prescribing the medication is different from the person filling out the checklist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences; Parstar boulevard; Qutb Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8739118631
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.093

Health conditions studied

1

Description of health condition studied
Spinal anesthesia
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anesthesia-induced headache during the puerperium

Primary outcomes

1

Description
Sensory block start time
Timepoint
It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours.
Method of measurement
Based on the Visual Analogue Scale and recorded in the checklist.

2

Description
Duration of anesthesia
Timepoint
It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours.
Method of measurement
Based on the Visual Analogue Scale and recorded in the checklist.

3

Description
Postoperative nausea and vomiting
Timepoint
They are measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours.
Method of measurement
The incidence and severity of postoperative nausea and vomiting are assessed based on the simplified criterion of postoperative nausea and vomiting (PONV scale).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A with 300 mg of oral gabapentin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L5-L4 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric bupivacaine for patients.
Category
Treatment - Drugs

2

Description
Intervention group: Group B, 150 mg Pregabalin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients.
Category
Treatment - Drugs

3

Description
Control group: Group C Oral placebo، Placebo capsule made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions after skin anesthesia with 2 CC lidocaine 2%, spinal anesthesia using cutting needle 25 and through the space between L4-L5 and L3-L4 vertebrae in The midline is performed with 15 mg of 0.5% hyperbaric Bupivacaine for patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Niloofar Barzegar
Street address
Kashan University of Medical Sciences; Parstar boulevard; Qutb Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
n.barzegar87@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Niloodar barzegar
Street address
Kashan University of Medical Sciences; Parstar boulevard; Qutb Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
n.barzegar87@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Niloofar Barzegar
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan University of medical sciences-Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Fax
Email
n.barzegar87@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Razavizadeh
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sabaye dahom alley; Zanbagh alley; Golha alley; Kashan-Amir Kabir street
City
Kashan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5554 0026
Email
mr_razavzi48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Niloofar Barzegar
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan University of medical sciences-Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Fax
Email
n.barzegar87@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts from 2020-2021
To whom data/document is available
Researchers
Under which criteria data/document could be used
For application or additional studies
From where data/document is obtainable
Send mail to n.barzegar87@gmail.com
What processes are involved for a request to access data/document
Request in person or by e-mail
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