Evaluation of the effect of using Ropivacaine injection after surgery in comparison with routine care on pain and nausea after surgery in patients candidate for mandibular orthognathic surgery.
Evaluation of postoperative topical injection of Ropivacaine, on postoperative pain and nausea, in mandibular orthognathic surgery.
Design
The two intervention and control groups each consisted of 10 male patients who were simply randomized and the study was double-blind.
Settings and conduct
Selection of patients who are candidate for mandibular surgery in the surgery department of Mashhad Dental School and then
Performing surgery in Ghaem Hospital of Mashhad
Participants/Inclusion and exclusion criteria
Gender of patients: Male
Entry conditions: Do not have systemic disease, especially kidney disease
No entry conditions: In terms of systematic classification, they are in ASA-I, ASA-II categories.
Intervention groups
In the intervention group, injections of Ropivacaine are performed after surgery.
In the control group, Ropivacaine is not injected.
Main outcome variables
A new guide to reducing common pain and nausea after mandibular orthognathic surgery with topical postoperative injection of Rupivacaine.
Response to disagreement about the effect of long-acting local anesthetics on postoperative pain and nausea in mandibular orthognathic surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041425N2
Registration date:2020-10-14, 1399/07/23
Registration timing:registered_while_recruiting
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Majid Hosseini Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
hoseiniabrishamim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using Ropivacaine injection after surgery in comparison with routine care on pain and nausea after surgery in patients candidate for mandibular orthognathic surgery.
Public title
The effect of ropivacaine on pain and nausea after maxillofacial surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients with mandibular defect
Examination in the surgical department of Mashhad Dental School and then performing mandibular orthognathic surgery in Ghaem Hospital of Mashhad
These patients are ASA-I and ASA-II in terms of systemic classification.
Exclusion criteria:
Existence of systemic disease, especially kidney disease
The need to use a drug outside the standard protocol of anesthesia or after surgery depending on the patient's condition
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In the intervention group, the patient and his clinical caregivers are unaware of Ropivacaine's injection that is done immediately after surgery.
Placebo
Not used
Assignment
Parallel
Other design features
--
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Science, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.081
Health conditions studied
1
Description of health condition studied
Mandibular surgery
ICD-10 code
M26.19
ICD-10 code description
Other specified anomalies of jaw-cranial base relationship
Primary outcomes
1
Description
Postoperative pain and nausea
Timepoint
1,3,6,12,18,24 Hours after surgery
Method of measurement
using pain and nausea questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Rupivacaine's injection after surgery
Category
Treatment - Drugs
2
Description
Do not inject Rupivacaine and perform routine care after surgery