Determining the preventive effect of sub acromial bupivacaine injection on acute pain after arthroscopic rotator cuff repair surgery
Design
A randomized, double-blind, randomized clinical trial are carried out on 64 patients.
Settings and conduct
This study will be performed in Shahid Rahnemoun Hospital in Yazd in 2021 .
A randomized, double-blind, randomized clinical trial are carried out on 64 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of rotator cuff rupture clinically and MRI result. Also people who have the ability to read, understand and record information.
Exclusion criteria: Patients with corrective or secondary surgery, patients with a history of trauma in the last 3 months, patients who have other surgeries in addition to rotator cuff repair.
Intervention groups
The first group is injected with bupivacaine and epinephrine one hour before the operation and the second group is injected with the same drugs after the operation.
Main outcome variables
Post-operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161225031559N5
Registration date:2022-02-05, 1400/11/16
Registration timing:retrospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Seyed Hossein Saeed-Banadaky
Name of organization / entity
Shahid Sadoughi Medical University
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0001
Email address
saeed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of sub acromial bupivacaine injection on acute pain after arthroscopic rotator cuff repair surgery
Public title
The effect of pre-operative shoulder analgesia on decrease post-operative pain after rotator cuff repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Diagnosis of rotator cuff rupture clinically and MRI result.
Conscious consent of the participants,
Patients who are able to read and write.
Exclusion criteria:
Exclusion criteria: Patients with corrective or secondary surgery,
patients with a history of trauma in the last 3 months,
patients who have other surgeries in addition to rotator cuff repair,
Patients who have mental health problems.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the blanced block randomization method is used to generate quadruple blocks. After the randomization sequence is prepared by the methodologist and using the sealedenvelope online site, the generated sequence will be provided to a technician. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is determined. Based on the randomly selected envelope, the patient is placed in group (A) preoperative injection or group (B) postoperative injection.
Blinding (investigator's opinion)
Double blinded
Blinding description
evaluators and statistical analysts are unaware.
The data are written in code A and B in which the analyst and evaluator do not interfere.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofEthics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.014
Health conditions studied
1
Description of health condition studied
Arthroscopic rotator cuff repair
ICD-10 code
S46.0
ICD-10 code description
Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
Primary outcomes
1
Description
Post-operative pain score
Timepoint
Pain before and after surgery and up to 3 days after surgery
Method of measurement
Questionnaire, Visual Analogue Scale
Secondary outcomes
1
Description
hours of sleep
Timepoint
Pre-operative and post-operative
Method of measurement
questionnaire, The sleep time is entered into the clock in the questionnaire.
Intervention groups
1
Description
First intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space space after surgery.
Category
Treatment - Drugs
2
Description
Second intervention group: 20 cc of bupivacaine, 0.25% of 40 micrograms of epinephrine will be injected into the sub acromial space one hour after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mojibian Hospital
Full name of responsible person
Amin Adeli Mirzaei
Street address
Kashani Street
City
Yazd
Province
Yazd
Postal code
8915635796
Phone
+98 35 3624 0061
Email
info@mojibian.ir
2
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Amin Adeli Mirzaei
Street address
Ebn Sina Street, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4009
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Amin Adeli Mirzaei
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Farokhi Street
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3312 2002
Email
amin_adeli21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Houssien Saeed-Banadaky
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Farokhi street
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3312 2002
Email
saeed@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Adeli Mirzaei
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Farokhi street
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3312 2002
Email
amin_adeli121@yahoo.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