In current prospective randomized double-blinded clinical trial, 20 patients aged between 20 to 65 years old candidate for shoulder surgery, with grade I or II of American society of anesthesiology (ASA), will be enrolled. Patients with psychotic disorders, obstructive pulmonary diseases and body mass index greater than 30 kg/m2, will be excluded. Anesthesia induction will be similar in all patients, using 0.03 mg/kg midazolam, 1-2 microgram/kg fentanyl, 2 mg/kg propofol and 0.15 mg/kg cisatracurium. At the end of the operation and subsequent to supine positioning of the patients interscalene block will be administered in both study groups via classic Winnie method. Injection spot will be determined by nerve stimulation and ultrasonography guidance. Subsequent to randomized allocation of patients to study groups, Interscalene block performed by 15 ml of 0.5% bupivacaine in the first group and by 30 ml of 0.25% bupivacaine in the second group. Pain severity measurement performed using quadruple pain scale (including no pain, mile pain, moderate pain and severe pain) in the recovery room and after discharge from recovery room measured by Visual Analogue Scale (VAS). Duration of analgesia considered as first requisition of patient to receive analgesics. Patients will be blinded to received bupivacaine dosage and anesthesiologist that records data will be blinded to patients study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050733848N1
Registration date:2017-05-25, 1396/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-25, 1396/03/04
Registrant information
Name
Taghi Abedini
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
anesth.deptbzmed@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Volume of Bupivacaine on Postoperative Pain After Shoulder Surgery Under Interscalene Block of Brachial Plexus
Public title
Bupivacaine effect on analgesia subsequent to brachial plexus block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 20 to 65 years old candidate for shoulder surgery; Class I or II according to ASA classification. Exclusion criteria: consumption of anti-psychotic drugs; drug abusers; history of psychotic disorders; obstructive pulmonary diseases; body mass index greater than 30 kg/m2; emergent operations; change in anesthesia or surgery procedure due to severe complications.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.TBZMED.REC.1395.1323
Health conditions studied
1
Description of health condition studied
Shoulder injuries
ICD-10 code
S40-S49
ICD-10 code description
Injuries to the shoulder and upper arm
Primary outcomes
1
Description
Patients pain severity after shoulder surgery during recovery
Timepoint
Postoperative recovery
Method of measurement
quadruple pain severity scale
2
Description
Patients pain severity after shoulder surgery during recovery
Timepoint
6 hours, 12 hours and 24 hours after surgery
Method of measurement
Using visual analogue scale
3
Description
duration of analgesia after shoulder surgery
Timepoint
Postoperative period
Method of measurement
Questionnaire
Secondary outcomes
1
Description
postoperative compliations hypotension
Timepoint
postoperative admission period
Method of measurement
Questionnaire
2
Description
postoperative nausea and vomiting
Timepoint
during admission
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: interscallen block will be applied by low dose bupivacaine including 15 ml of 0.5% bupivacaine solution.
Category
Treatment - Drugs
2
Description
Study group: interscallen block will be applied by low dose bupivacaine including 30 ml of 0.25% bupivacaine solution.