Survey of the effect of gabapentin on post-operative pain of shoulder rotator cuff surgery
Design
Double blinded randomized clinical trial
Settings and conduct
Intervention group: Patients in group G will receive 300 mg of gabapentin at 6 pm on the first day after surgery and 600 mg of gabapentin in divided doses at 6 am and 6 pm on the second and third days.
Control group: Patients in group P will receive one placebo on the first day after surgery at 6 pm and on the second and third days after taking placebo in two divided doses at 6 am and 6 pm.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients undergoing shoulder rotator cuff surgery ,Age 30-65 years old, (ASA) I-II.
Exclusion criteria:Sensitivity to gabapentin History of hypertension Heart disease Liver and kidney disease Acute or chronic pain associated with other areas of the body Any dependence on narcotics and psychotropic drugs Continuous use of tranquilizers for depression and anxiety disorders and seizure disorders.
Intervention groups
Intervention group: Patients in group G will receive 300 mg of gabapentin at 6 pm on the first day after surgery and 600 mg of gabapentin in divided doses at 6 am and 6 pm on the second and third days.
Control group: Patients in group P will receive one placebo on the first day after surgery at 6 pm and on the second and third days after taking placebo in two divided doses at 6 am and 6 pm.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003213N9
Registration date:2020-05-19, 1399/02/30
Registration timing:prospective
Last update:2020-05-19, 1399/02/30
Update count:0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Arash Farbood
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
farboda@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of gabapentin on post-operative pain of shoulder rotator cuff surgery
Public title
Survey of the effect of gabapentin on post-operative pain of shoulder rotator cuff surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing shoulder rotator cuff surgery
Age 30-65 years old
(ASA) I-II
Exclusion criteria:
Sensitivity to gabapentin
History of hypertension
Heart disease
Liver and kidney disease
Acute or chronic pain associated with other areas of the body
Any dependence on narcotics and psychotropic drugs
Continuous use of tranquilizers for depression and anxiety disorders and seizure disorders
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurse prescribing the medication, the patient, and the data collector will be unaware of the patient's study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.SUMS.MED.REC.1398.572
Health conditions studied
1
Description of health condition studied
Shoulder rotator cuff surgery
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Pain
Timepoint
The severity of pain is measured by Numeric Rating Scale , every 2 hours to 6 hours, and then every 6 hours to 24 hours.
Method of measurement
Numeric Rating Scale (NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in group G will receive 300 mg of gabapentin at 6 pm on the first day after surgery and 600 mg of gabapentin in divided doses at 6 am and 6 pm on the second and third days.
Category
Treatment - Drugs
2
Description
Control group: Patients in group P will receive one placebo on the first day after surgery at 6 pm and on the second and third days after taking placebo in two divided doses at 6 am and 6 pm.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Samira Safari
Street address
Shahid Chamran Hospital, Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 71 3624 0101
Email
chamranhosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Vice chancellor of research, 7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Samira Safari
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7156948623
Phone
+98 71 3647 4270
Email
Safari.anest@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Farbood
Position
Anesthesiologist/Pain Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 36474270
Email
arashfarbood@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Farbood
Position
Anesthesiologist/Pain Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 36474270
Email
arashfarbood@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD