To examine the effect of a single one-time pregabalin dose on post-operative pain, anxiety and analgesic consumption after vitrectomy performed under peribulbar block
Design
Patients was randomly divided into 2 groups. The groups are parallel. The trial phase is 2-3
Settings and conduct
Candidates for vitreo-retinal surgery in Magrabi Eye, ENT and Dental Center, Doha, Qatar are divided into 2 groups. The groups are parallel. The trial phase is 2-3.
Participants/Inclusion and exclusion criteria
Exclusion criteria were; patients ‘refusal to regional anesthesia, patients more than 75 years old, pregnancy, breast-feeding women, bleeding tendency, history of drug abuse, renal insufficiency, neurological or psychiatric disorders, or allergy to the study medication, intake of narcotic analgesics, pregabalin or benzodiazepines, within 24hrs before the study. Patients aged 18 and older who consented to participate in this study and who do not have exclusion criteria were included in our study
Intervention groups
A total of 58 patients were involved in this study. The pregabalin group composed of 30 cases who received pregabalin 150 mg as premedication and the placebo group involved 28 patients who received placebo.
Main outcome variables
Post-operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210117050057N1
Registration date:2021-01-26, 1399/11/07
Registration timing:prospective
Last update:2021-01-26, 1399/11/07
Update count:0
Registration date
2021-01-26, 1399/11/07
Registrant information
Name
Mohamed Oriby
Name of organization / entity
Faculty of Medicine, Tanta University
Country
Egypt
Phone
+20 3 3059056
Email address
oraiby500@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-01, 1399/11/13
Expected recruitment end date
2021-04-01, 1400/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Postoperative Anxiolytic and Analgesic Effects of Pregabalin in Vitreo-Retinal Surgery: A randomized double-blind study
Public title
Postoperative Anxiolytic and Analgesic Effects of Pregabalin in Vitreo-Retinal Surgery: A randomized double-blind study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 and older
Consented to participate in this study
Exclusion criteria:
Patients' refusal to regional anesthesia
Patients more than 75 years old
Pregnancy
Breast-feeding women
Bleeding tendency
History of drug abuse
Renal insufficiency
Neurological or psychiatric disorders or allergy to the study medication
Intake of narcotic analgesics, pregabalin or benzodiazepines, within 24hrs before the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Independent technician was responsible for computer-generated codes to be able to obtain complete randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
These codes were kept in sealed envelopes which are sequentially numbered and opaque. A nurse who was not involved in the study opened these envelops immediately before administration
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board (IRB) of Magrabi Eye & ENT Center
Street address
D ring road
City
Doha
Postal code
23293
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
MEEC-IRB- 2021-101
Health conditions studied
1
Description of health condition studied
Vitreo-Retinal surgery
ICD-10 code
H33
ICD-10 code description
Elective retinal surgeries
Primary outcomes
1
Description
Postoperative Pain
Timepoint
Postoperatively
Method of measurement
Verbal analogue pain score (VAS)
Secondary outcomes
1
Description
Anxiety
Timepoint
Postoperatively
Method of measurement
Verbal anxiety score
2
Description
Analgesic consumption
Timepoint
Postoperatively
Method of measurement
Calculation of analgesics consumed
Intervention groups
1
Description
Control group: Controlled (Placebo) group involved 28 patients who received placebo drugs as premedication
Category
Treatment - Drugs
2
Description
Intervention group: Case (Pregabalin) group involved 30 patients who received Pregabalin capsule 150 mg as premedication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Full name of responsible person
MOHAMED ORIBY
Street address
D ring road
City
Doha
Postal code
23293
Phone
+974 4437 5046
Email
oraiby500@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Full name of responsible person
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Street address
D ring road
City
Doha
Postal code
23293
Phone
+974 4437 5046
Email
oraiby500@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Magrabi Eye, ENT and Dental Center, Doha, Qatar
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+20 3 3059056
Email
oraiby500@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+20 3 3059056
Fax
Email
oraiby500@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+20 3 3059056
Fax
Email
oraiby500@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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