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Interscalen brachial plexus blockade combined with Perineural dexamethasone for post operative analgesia after shoulder surgery

Protocol summary

Study aim
Investigating the effect of perineural dexamethasone combination in brachial plexus interscalene block in shoulder surgery on postoperative pain
Design
During this RCT, the number of 60 patients candidates for shoulder surgery are allocated randomly into 2 groups of 30 patients according to Including and excluding criteria. In the control group, lidocaine 2 cc (1.5%) , bupivacaine 20 mg (2cc, 0.5%) , and 2 cc normal saline are used for interscalene block. In the case group, lidocaine 2 cc (1.5%) , 2cc bupivacaine 0.5% (20mg), and 2cc dexamethasone (8mg) are used. VAS score is used to measure pain 12 hours and 24 hours after the operation
Settings and conduct
During this RCT, the number of 60 patients candidates for shoulder surgery are allocated randomly into 2 groups of 30 patients according to Including and excluding criteria. In the control group, lidocaine 2 cc (1.5%) , bupivacaine 20 mg (2cc, 0.5%) , and 2 cc normal saline are used for interscalene block. In the case group, lidocaine 2 cc (1.5%) , 2cc bupivacaine 0.5% (20mg), and 2cc dexamethasone (8mg) are used. VAS score is used to measure pain 12 hours and 24 hours after the operation This research is double-blind and the physician injecting the drugs and the physician performing the post-operative evaluations are different and do not know about the content of the syringes and the cases.
Participants/Inclusion and exclusion criteria
Patients with ASA class I and II candidates for shoulder surgery referred to Shohadaye Tajrish and Akhtar Hospitals affiliated to Shahid Beheshti University of Medical Sciences.
Intervention groups
In the control group, 30 cc lidocaine1.5%, 2cc bupivacaine 0.5%(20mg), and 2cc of normal saline are injected between the C5-C6 roots of spine. In the case group, 30cc lidocaine 1.5%, 2 cc bupivacaine 0.5%(20 mg), 2cc of dexamethasone 8mg is injected between the same roots
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170423033615N3
Registration date: 2023-10-14, 1402/07/22
Registration timing: retrospective

Last update: 2023-10-14, 1402/07/22
Update count: 0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Mahshid Ghasemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 5454
Email address
mahshidghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interscalen brachial plexus blockade combined with Perineural dexamethasone for post operative analgesia after shoulder surgery
Public title
Interscalen brachial plexus blockade combined with Perineural dexamethasone for post operative analgesia after shoulder surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I , ASA II Candidate for shoulder surgery No substance abuse in the past 6 weeks No orthopedic surgery in the lower limb under spinal anesthesia no respiratory diseases, diabetes; Cardiovascular no drug addiction according to definition Normal body temperature No history of shivering No history of seizures Absence of tremors or Parkinson's Not taking NSAIDs 24 hours before surgery Absence of infection or wound No Allergy to local anesthetics Not pregnant and breastfeeding Duration of surgery maximum 3 hours No allergy to Estroids
Exclusion criteria:
History of psychiatric disorders patient refusal or inability to give informed consent ASA class III and above anticoagulants History of adverse reactions to steroids History of adverse reactions to local anesthetics History of drug abuse Occurrence of complications that require intervention within 24 hours after the operation receiving blood transfusion during surgery or anesthesia central body temperature to less than 32 degrees Celsius during surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, based on the table of random numbers, first the number of samples is entered using a computer, and for each patient two-digit code is assigned . The researcher randomly selects a point in the Weston line. If the number is smaller than the sample size, the selection is made. And this continues until the sample size is complete
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the drugs of the case group and the control group are drawn into the syringe by the nurse anesthetist. Therefore, the nurse is aware of the types of drugs of the two groups. The researcher, who is an anesthesiologist, does not know which group the drug belongs to. So the researcher is blind at this stage. On the other hand, the participants of the study are also blind to the difference of drugs in each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Abbas Arabi Street, Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.754

Health conditions studied

1

Description of health condition studied
post operation pain in shoulder surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
12 hours after the operation, 24 hours after the operation
Method of measurement
VAS Score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group,the combination of lidocaine 1.5% in the amount of 2 cc, bupivacaine 0.5% in the amount of 2 cc (20 mg), and 2 cc of dexamethasone (8 mg) are injected between the roots of C5-C6 cervical spine.
Category
Treatment - Surgery

2

Description
Control group: the combination of 30 cc lidocaine1.5%, 2cc bupivacaine 0.5%(20mg), and 2cc of normal saline are injected between the C5-C6 roots of spine
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Faranak Behnaz MD
Street address
Shahrdari Str, Tajrish Sqr,
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 912 203 9978
Email
faranak_behnaz@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Mahshid Ghasemi MD
Street address
Sharifi Manesh Str, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 912 154 8175
Email
mahshidghasemi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Ave
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi MD
Position
Associate professor in Anesthesia, Pain medicinefellowship
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship in Pain medicine
Street address
Pain Clinic, Akhtar Hospital, Shariati str, Sharifi Manesh Ave
City
TEHRAN
Province
Tehran
Postal code
1964714953
Phone
+98212201072
Email
mahshidghasemi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi MD
Position
Associate professor in Anesthesia, Pain medicinefellowship
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship in Pain medicine
Street address
Pain Clinic, Akhtar Hospital, Shariati str, Sharifi Manesh Ave
City
TEHRAN
Province
Tehran
Postal code
1964714953
Phone
98212201072
Email
mahshidghasemi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi MD
Position
Associate professor in Anesthesia, Pain medicinefellowship
Latest degree
Subspecialist
Other areas of specialty/work
Fellowship in Pain medicine
Street address
TEHRAN
City
TEHRAN
Province
Tehran
Postal code
1964714953
Phone
+98212201072
Email
mahshidghasemi@sbmu.ac.ir

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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the initial implications
When the data will become available and for how long
since 2023
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Mahshid Ghasemi MD, mahshidghasemi@sbmu.ac.ir
What processes are involved for a request to access data/document
Send a request by e-mail
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