Excellent postoperative pain control plays central role in the outcome of open shoulder surgery which provides early rehabilitation and accelerates functional recuperation. Interscalen Brachial Plexus Block is one of the most common performed block for upper limb surgery which has low incidence of complication and can be performed easily by anesthesiologists. In this study we evaluate the effect of low dose interscalen brachial plexus block on recovery parameters of patients undergoing shoulder surgery. Fifty patients who are candidate for elective shoulder surgery will be enrolled in this study. Inclusion criteria is every adult patient who candidate for elective shoulder surgery and can tolerate a 25% decrease in lung capacities (Forced vital capacity) and exclusion criteria are infection in site of block, coagulopathy, neuropathy, history of damage to brachial plexus and allergy to local anesthetic. Patients will be randomized to two 25-patient groups. One group will receive morphin sulfate and in the other group small volume Interscalene Brachial Plexus Block (ISBPB) will be performed. Pain severity, patient satisfaction scores and post anesthesia recovery parameters (agitation, Post Anesthetic Care Unit length of stay, eyes opening and reply to verbal stimulation) will be assessed. Primary outcome is recovery parameters like pain, patient satisfaction, agitation, eyes opening, reply to verbal stimuli and secondary outcome is discharge from PACU (Post Anesthetic Care Unit).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011072582N2
Registration date:2010-12-25, 1389/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-25, 1389/10/04
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-10-20, 1389/07/28
Expected recruitment end date
2011-10-20, 1390/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of low dose interscalene block in addition to general anesthesia on recovery parameters from anesthesia in shoulder surgery
Public title
Efficacy of Interscalen block in shoulder surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: every adult patient who are candidate for elective shoulder surgery and can tolerate a 25% decrease in lung capacities (Forced vital capacity). Exclusion criteria: infection in site of block, coagulopathy, neuropathy, history of damage to brachial plexus and allergy to local anesthetic.
Age
From 18 years old to 81 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2009-05-20, 1388/02/30
Ethics committee reference number
88/1-4/3
Health conditions studied
1
Description of health condition studied
post operative pain
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
2
Description of health condition studied
post operative pain
ICD-10 code
Y83
ICD-10 code description
Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
recovery parameters
Timepoint
During PACU (post anesthetic care unit) stay
Method of measurement
Visual analogue scale for pain, Two point score for patient satisfaction, Ramsey score for agitation, eyes opening by verbal stimuli
Secondary outcomes
1
Description
patient discharge
Timepoint
duration of post anesthetic care unit
Method of measurement
hours of PACU stay
Intervention groups
1
Description
Intervention; general anesthesia plus low dose interscalen block with 20 ml of lidocaine 1.5%
Category
Treatment - Other
2
Description
Control: only General anesthesia same as the intervention group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
El-goli street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Faculty of Health and Nutrition
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
PhD of Nutrition, Associated Professor, director of research program
Other areas of specialty/work
Street address
Health and Nutrition faculty
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
aostadrahimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU/ Assistant professor
Other areas of specialty/work
Street address
General ICU, Shohada Hospital, El-Goli street
City
Tabriz
Postal code
Phone
+98 41 1385 1117
Fax
+98 41 1385 3171
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)