Background and Objectives: Effective post- operative pain control is an important factor in reducing the incidence of morbidity and in promoting early mobilization and discharge from hospital. Wound infiltration with a local anesthetic for post- operative pain relief following surgery of zygomatico maxillary complex (Zmc) fracture, seems to be an attractive method because of its simplicity , safety and low cost. This study intends to determine if this method could reduce post operative pain and complications as well as the amount of post operative analgesics requirements.
Design: Sixty patients with Zmc fracture who are candidate for open reduction with intra and extra oral approaches, will be recruited. Main inclusion criteria are patients under going open reduction with intra and extra oral approaches for(Zmc) fracture and main exclusion criteria are history of addiction , seizure and psychopathic conditions. After providing written consent form, they will be randomly divided into the two groups: study group will undergo infiltration of 10 ml bupivacaine at the site of incision while the control group will receive placebo.At the end of the study two groups will be compared in terms of pain and analgesic consumption at various times after operation. Inclusion: age from 20 to 60 people who are going to have open reduction for Zygomatic fracture Exclusion criteria : Addiction, Seizure, psychopathic conditions and refuse to participate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406201772N14
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical science/ Vice chancellor of reseach
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Long-acting local anesthetic infiltration in surgical wound for post operative pain control in zygomatico maxillary complex fracture
Public title
post operative pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: age from 20 to 60 people who are going to have open reduction for Zygomatic fracture
Exclusion criteria : Addiction, Seizure, psychopathic conditions and refuse to participate.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical science ,fuculty of dentistry/ reseach ethical committee
Street address
Daneshghah street/ Tabriz university of medical science/fuculty of dentistry/ Vice chancellor of reseach/ ethical committee
City
Tabriz
Postal code
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
9338
Health conditions studied
1
Description of health condition studied
post operative pain control
ICD-10 code
T41.3
ICD-10 code description
local Anesthetic
Primary outcomes
1
Description
Pain
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid cosumption
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Total Dose
Intervention groups
1
Description
Surgical site infiltrated before wound closure with 10 ml Bupivacaine 0.5%
Category
Treatment - Drugs
2
Description
Surgical site infiltrated before wound closure with placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Imam Reza Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical science/ Vice chancellor of reseach
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin
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 science/ Vice chancellor of reseach
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 science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin Tabriz
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)