Determining the effect of pain control from gabapentin and pregabalin after Percutaneous nephrolithotomy
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 2, on 66 patients. A random number table will be used for randomization.
Settings and conduct
The aim of this study was to determine the effect of pain control from gabapentin and pregabalin after Percutaneous nephrolithotomy. This study is a single blind, randomized clinical trial. The study population is patients undergoing Percutaneous nephrolithotomy. Patients will receive randomly pregabalin capsules 150 mg, gabapentin capsules 300 mg and placebo capsules in 3 intervention groups. The patient will be unaware of the group assigned to him.
Participants/Inclusion and exclusion criteria
Inclusion criteria for participants: Patients undergoing percutaneous nephrolithotomy surgery, ASA class I, II, age between 20-60 years, patient informed consent. Exclusion criteria for participants: age under 20 years and over 60 years, history of preoperative renal dysfunction, history of cardiovascular or lung diseases.
Intervention groups
Intervention group 1: Patients will receive a 150 mg pregabalin capsule two hours before surgery. Intervention group 2: Patients will receive gabapentin 300 mg capsule two hours before surgery. Control group: Patients will receive placebo capsules two hours before surgery.
Main outcome variables
The main outcome of the study: pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200802048275N1
Registration date:2021-01-06, 1399/10/17
Registration timing:prospective
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Leila Seyedtabaii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7742 0933
Email address
leiladrml@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of preoperative administration of gabapentin and pregabalin on pain control after percutaneous nephrolithotomy
Public title
Effect of gabapentin and pregabalin on pain control after percutaneous nephrolithotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient undergoing percutaneous nephrolithotomy
Class ASA I, II
Age between 20-60 years
Patient informed consent
Exclusion criteria:
Age under 20 years and over 60 years
History of preoperative renal dysfunction
History of cardiovascular or lung disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients receive a random number using the random number table according to their priority entry to the center that matches the numbers on the sealed envelopes. Inside the sealed envelopes is one of the codes A, B and C. A represents the first intervention group that will receive 20 ml of sterile normal saline, B represents the second intervention group that will receive 40 ml of sterile normal saline, and C represents the third intervention group that will receive 60 ml of normal sterile saline. The number of patient in each group is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants are not aware of their assigned group and will be unaware of the drug used. Of course, they participate in the study with informed consent.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.IUMS.FMD.REC.1399.277
Health conditions studied
1
Description of health condition studied
Percutaneous nephrolithotomy
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Pain
Timepoint
Before surgery, recovery, 4, 6 and 12 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: wo hours before surgery, a 150 mg pregabalin capsule is given.
Category
Treatment - Drugs
2
Description
Intervention group: two hours before surgery, a 300 mg gabapentin capsule is given.
Category
Treatment - Drugs
3
Description
Control group: two hours before surgery, a placebo capsule is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminejad Hospital
Full name of responsible person
Masoud Ghorbanloo
Street address
Shahid Valinejad Alley, Above Vanak Square, Vali Asr St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
support@hkc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Fax
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masoud Ghorbanloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hashemi nezhad Hospital, Shahid Valinejad Alley, Above Vanak Square, Vali Asr St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
masoudghorbanlo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoud Ghorbanloo
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hashemi nezhad Hospital, Shahid Valinejad Alley, Above Vanak Square, Vali Asr St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
masoudghorbanlo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Sadat Seyed Tabaei
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Valinejad Alley, Above Vanak Square, Vali Asr St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Fax
Email
leiladrml@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Dr. Massoud Ghorbanloo
What processes are involved for a request to access data/document
After reviewing the applicant's request, it will be sent to him.