Oculo-cardiac reflex (OCR) defined as bradycardia induced by manipulation of extra-ocular muscles, is a serious complication during strabismus surgery which requires prevention and attention in management.
purpose:
In the present study we investigated efficacy of sub-tenon injection of bupivacaine in prevention of OCR and management of post-operative pain.
method:
50 patients who are candidate for strabismus surgery will randomize in case (bupivacaine injection) and control (sterile saline injection) groups and standard strabismus surgery will perform for all cases. inclusion criteria included all 8-17 years old patients admitted in Khalili Hospital for strasbismus surgery on orbital rectus muscles and Exclusion criteria included addiction,
previous operation on same muscle, diabetic patients and mental retard patients. Occurrence and severity of OCR and post-operative pain were compared between two groups.
Patients randomly receive sub-Tenon’s injection of 0.1 ml of 0.5% bupivacaine solution or sterile saline which previously prepare in similar vials specify with codes unknown to the surgeon and the study executor who evaluate pain and monitored the patient during the operation for measurement of oculocardiac reflex. Injection of bupivacaine or placebo solution will perform using a curved blunt 19 gauge cannula. Surgical resection or recession of the medial or lateral rectus muscles start 5 minutes after sub-tenon injection through the same conjunctival aperture use for injection. Surgical technique will be similar for all patients (recess, resect or both) and the same surgeon perform the operations.
During the operation, patients continuously monitor by electrocardiography, pulse oximetry, capnography and blood pressure. Pulse rate will be monitored during manipulation of the rectus muscles and the minimal recorded pulse rate will be used for measurement and comparison of oculocardiac reflex. Executor will scale patient's pain in recovery room as patients score it between 0-10. 10 is indicative of the most severe pain imaginable and zero represents no feeling of pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091714694N1
Registration date:2015-05-24, 1394/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
mohammad reza taleb nezhad
Name of organization / entity
Shiraz medical school
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
ghanim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-09-20, 1393/06/29
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sub-tenons bupivacaine on oculocardiac reflex during strabismus surgery and post-operative pain
Public title
The effect of sub-tenons bupivacaine on oculocardiac reflex during strabismus surgery and post-operative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
all 8-17 years old patients admitted in Khalili Hospital for strabismus surgery on orbital rectus muscles
Exclusion criteria:
Addiction ; Previous operation on same muscle ; Diabetic patients ; Mental retard patients
Age
From 8 years old to 17 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
92-01-01-5808
Health conditions studied
1
Description of health condition studied
Oculocardiac reflex during strabismus surgery and Post operation pain
ICD-10 code
H50.3
ICD-10 code description
Intermittent strabismus
Primary outcomes
1
Description
Pain
Timepoint
30 minutes after operation an 10ur after
Method of measurement
By patients scoring between 1 to 10
2
Description
Heart rate
Timepoint
Before stretching of rectus muscle and during stretching
Method of measurement
Monitoring
Secondary outcomes
1
Description
Nausea, Vomiting
Timepoint
Immediately after surgery and 2days after surgery
Method of measurement
History taking
Intervention groups
1
Description
1 time sub tenon injection of 0.1ml bupivacaine 5%(5mg in 100ml) in case group 5 minutes before starting surgery
Category
Treatment - Drugs
2
Description
sub tenon injection of 0.1ml normal salin in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Doctor Mohamad Reza Talebnejad
Street address
Khalili Hospital, Khalili Street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Grant name
پابان نامه دانشجویی
Grant code / Reference number
010010
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohamad Reza Talebnejad
Position
Pediatric Ophthalmology and Strabismus / Head of Research Center of Ophthalmology Poostchi
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
talebmor@sums.ac.irtalebnejadmr@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Reza Talebnejad
Position
Pediatric Ophthalmology and Strabismus
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
Talebmor@sums.ac.irTalebnejadmr@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mohamad Reza Talebnejad
Position
Pediatric Ophthalmology and Strabismus / Head of Research Center of Ophthalmology Poostchi
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
talebmor@sums.ac.irtalebnejadmr@yahoo.com
Web page address
Psorc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)