Goal of study:evaluation the benefits of adding corticosteroids to injection of local anesthesia in reducing the pain and need for analgesics after nasal surgeries.
Design of study: a randomized, double-blind,case & control groups,with no placebo, single center.
A-Population: All patients requiring nasal surgery
-Terms of inclusion:
All patients who admtited for different nasal sugeries and went under general anesthesia in Imam Khomeini Hospital in Ahwaz.
-Terms of exclusion:
Having a history of major cardiovascular diseases, hypertension, cerebrovascular accidents, diabetes,eye problems or a history of hypersensitivity to local anesthetic agents such as lidocaine or their preservative compounds.
- Sample: 60 patients
B- Interventions: local injections(nerve blocks) in nasal area using Dexamethasone with Marcaine(Bupivacaine) against Marcaine.
C- Time of intervention:Before nasal surgery and after induction of general anesthesia.
D- Outcomes studied: Reduce the pain or application of oral/injectable analgesics after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104256288N1
Registration date:2011-09-04, 1390/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-04, 1390/06/13
Registrant information
Name
Mahmood Hekmat shoar
Name of organization / entity
Ahwaz Jundi shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3477
Email address
hekmat-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundi shapour University of Medical Sciences.
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local anaesthetic effect of Bupivacaine ( Marcaine ) VS Bupivacaine and Dexamethasone in Nasal Surgery in Imam hospital of Ahwaz.
Public title
The role of adding topical corticosteroids in anesthesia and analgesia after nasal surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
All patients who admtited for nasal sugery(closed reduction of nasal bone fracture(NBF), septoplasty, rhinoplasty, endoscopic sinus surgery (FESS) or a combination of them) and went under general anesthesia in Imam Khomeini Hospital in Ahwaz.
Exclusion Criteria:
1- Not in the specified age range.
2- Having a history of major cardiovascular diseases, hypertension, cerebrovascular accidents, diabetes and eye problems.
3- Having a history of hypersensitivity to local anesthetic agents such as lidocaine or their preservative compounds.
4- Lack of satisfaction or cancellation to participate in the study.
5- Not undergoing general anesthesia for any reason.
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundi shapour University of Medical Sciences
Street address
Department of research and technology,Ahwaz Jundi shapour University of Medical Sciences,University center,Golestan highway.Post box:45
City
Ahwaz
Postal code
61357-15794
Approval date
2011-06-18, 1390/03/28
Ethics committee reference number
ETH-169
Health conditions studied
1
Description of health condition studied
local anaesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
2
Description of health condition studied
Closed reduction of nasal bone fracture
ICD-10 code
S02.2
ICD-10 code description
Fracture of nasal bones
3
Description of health condition studied
Septoplasty
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
4
Description of health condition studied
Rhinoplasty
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
5
Description of health condition studied
FESS(Functional endoscopic sinus surgery)
ICD-10 code
J32,J33
ICD-10 code description
Chronic sinusitis,Nasal polyp
Primary outcomes
1
Description
The amount of postoperative pain
Timepoint
1,2,4,6,12,24 houres after surgery
Method of measurement
Visual Analog Scale(VAS)
2
Description
The need for oral or injectable analgesic drugs
Timepoint
In the first 24 hours after surgery
Method of measurement
Frequency of use of acetaminophen 325mg (oral tablets) or pethidine 20mg(intravenous injection)
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, injectable solution of Marcaine is used for nerve blocking(Incisive nerve (columellar area),bilateral Infraorbital nerves and Supratrochlear nerves) during surgery and immediately after general anesthesia.
We used 5-20 cc of 0.5% Marcaine solution (dose=1-1.5 mg/kg,max dose=100 mg per patient).
Category
Other
2
Description
In the intervention group, injectable solution of Marcaine + Dexamethasone is used for nerve blocking(Incisive nerve (columellar area),bilateral Infraorbital nerves and Supratrochlear nerves) during surgery and immediately after general anesthesia.
We used 5-20 cc of 0.5% Marcaine solution (dose=1-1.5 mg/kg,max dose=100 mg per patient) and 2-8 mg of Dexamethasone solution in each patient(dose=0.1 mg/kg).