Effectiveness of pregabalin compared to the placebo group in improving pain after anterior cruciate ligament reconstruction surgery in the acute phase, in patients referred to Akhtar Hospital in 1402
Design
Two arm parallel group randomized Double-Blind phase 2 trial in 132 patients who undergo ACL reconstruction surgery
Settings and conduct
This double-blind study will evaluate the analgesic effect of pregabalin. Participants will randomly assign to receive pregabalin or a different placebo, with both supervising personnel and participants unaware of the method used, and unbiased assessment of pain relief and ensure its delivery. Potential sources of outcome assessor bias will be blinded. The purpose of the careful design of this study is to provide strong evidence for the analgesic effect of pregabalin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-45 year old patients who undergo arthroscopic anterior cruciate ligament reconstruction surgery.
Exclusion criteria: (1) any known allergy or contraindication to pregabalin. (2) History of heart, kidney or liver disease. (3) Preoperative use of antidepressants or anticonvulsants. (4) history of drug or alcohol addiction; (5) Nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids use 48 hours before surgery. (6) Meniscus repair or allograft use.
Intervention groups
Pregabalin group: single dose of pregabalin 150 mg 2 hours before surgery
Placebo group: one dose of placebo before surgery
Main outcome variables
Pain measured using Numeric pain scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059098N1
Registration date:2023-11-29, 1402/09/08
Registration timing:registered_while_recruiting
Last update:2023-11-29, 1402/09/08
Update count:0
Registration date
2023-11-29, 1402/09/08
Registrant information
Name
Emad Kouhestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 9182
Email address
emadkouhestani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Pregabalin compared to placebo in management of acute postoperative pain after anterior cruciate ligament (ACL) reconstruction surgery
Public title
Effect of Pregabalin on postoperative pain after anterior cruciate ligament (ACL) reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 who undergo arthroscopy for anterior cruciate ligament reconstruction in Akhtar Hospital in 1402 are included in the study.
Exclusion criteria:
Any known allergies or contraindications to pregabalin
History of heart, kidney or liver disease
Preoperative use of antidepressants or anticonvulsants
History of drug or alcohol addiction
Nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids use 48 hours before surgery
Patients who underwent meniscus reconstruction or allografts were used
Age
From 18 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized clinical trial study, patients are placed in each of the two groups according to the simple randomization method in a 1:1 ratio. The assigned group for each person is notified to the surgeon by a sealed letter.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients are studied with random identification codes assigned to them by the researcher. Patients and the person in charge of data collection are blinded to the type of patient group. Patients will be unaware of which study group they are in. Both intervention and control groups receive similar recommendations. The person in charge of data collection will be unaware of the treatment group of each patient and will record the results only based on the identification code of the people.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shariati street
City
Tehran
Province
Tehran
Postal code
199871793
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.346
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
Postoperative pain
Timepoint
6, 12, 24 hours postoperatively
Method of measurement
Numeric pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A single dose of pregabalin from Tehran Shimi Company, 150 mg, is taken 2 hours before surgery with a glass of water.
Category
Treatment - Drugs
2
Description
Control group: A single dose placebo (capsule containing sucrose with the same shape and color as pregabalin capsule) is taken with a glass of water 2 hours before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Emad Kouhestani
Street address
Sharifi Manesh street
City
Tehran
Province
Tehran
Postal code
199871793
Phone
+98 21 2260 1761
Email
emadkouhestani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Akhtar Hospital Research Center
Full name of responsible person
Emad Kouhestani
Street address
Sharifi Manesh street
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2260 1761
Email
emadkouhestani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Akhtar Hospital Research Center
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emad Kouhestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifi Manesh street
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2260 1761
Email
emadkouhestani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emad Kouhestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifi Manesh street
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2260 1761
Email
emadkouhestani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emad Kouhestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifi Manesh street
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2260 1761
Email
emadkouhestani@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Collected deidentified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
Deidentified data will be available starting from May, 2023.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
No specific condition
From where data/document is obtainable
Email Emad Kouhestani to obtain data
emadkouhestani@gmail.com
What processes are involved for a request to access data/document
The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in one month.