survey of the effect of posterior tibial and sural nerves block on postoperative pain control patients following ORIF of calcaneus fracture through lateral extensive approach .
survey of the effect of posterior tibial and sural nerves block on postoperative pain control in patients following external reduction and internal fixation of calcaneous fracture through lateral extensive approach
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
50 patients in two groups of 25 will be compared in the Chamran Hospital,Shiraz.patients in the first group will be under Tibial and Sural nerve block 30 - 60 min before induction of anesthesia by injecting 10 ml of bupivacaine 0.5% in the superior aspect of internal maleoulous and then 10 ml of 0.5 % bupivacaine in the lateral maleoulous.While patients in the control group undergoing surgery without any nerve block.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with distal fracture of the calcaneous and candidate for external reduction and internal fixation of calcaneous fracture through lateral extensive approach; age 18 to 55 years old; (ASA I-II);Exclusion criteria: Consumption of analgesic drugs or opiate ,renal failure; hepatic failure and BMI>35
Intervention groups
Intervention group:
Patients in group B will be under Tibial and Sural nerve block 30 - 60 min before induction of anesthesia by injecting 10 ml of bupivacaine 0.5% in the superior aspect of internal maleoulous and then 10 ml of 0.5 % bupivacaine in the lateral maleoulous.
Control group:patients in the control group will be undergo of surgery without any nerve block.
Main outcome variables
Pain and time of the first demand for morphine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N1
Registration date:2018-12-01, 1397/09/10
Registration timing:prospective
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
survey of the effect of posterior tibial and sural nerves block on postoperative pain control patients following ORIF of calcaneus fracture through lateral extensive approach .
Public title
survey of the effect of posterior tibial and sural nerves block on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Distal fracture of the calcaneus bone and the candidate of the surgical reduction and internal fixation
Age18 - 55 years old
ASA I-II
Exclusion criteria:
The patient has a history of misuse of any analgesic or opiate
Renal failure
Hepatic failure
Localized infection in the affected leg
BMI of> 35
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized according to the charts which was derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person evaluating the patient after the surgery are unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Double blind randomize clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.SUMS.MED.REC.1397.142
Health conditions studied
1
Description of health condition studied
Fracture of calcaneus
ICD-10 code
S92.00
ICD-10 code description
Unspecified fracture of calcaneus
Primary outcomes
1
Description
First demand for morphine
Timepoint
Post-operative
Method of measurement
Observation
2
Description
Pain
Timepoint
Every 5 min in the recovery room and every 2 hours in the ward at the first 6 hours and then every 4 h until 24 h.
Method of measurement
NRS
Secondary outcomes
1
Description
Patients Satisfaction
Timepoint
Postoperatively
Method of measurement
Likert Scale
Intervention groups
1
Description
Intervention group: Patients will be placed half an hour before entering the operating room by injecting 10 ml of bupivacain 0.5% in the superior medial ankle and then 10 ml of 0.5% bupivacaine in the supperior aspect of lateral ankle under the posterior tibial nerve block and Sural nerve after induction of anesthesia Surgery will be performed.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will be undergo surgery without posterior Tibial and Sural nerve block.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Bita Hamzeh Moghadam
Street address
Chamran Blvd/Chamran Hospital
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1407
Fax
+98 71 3628 1506
Email
drtabib.maryam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes Ghasemi
Street address
Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bita Hamzeh Moghadam
Position
پزشک /رزیدنت بیهوشی
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
Bita55md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Farbood
Position
Fellowship of pain/Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Tabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3628 1506
Email
drtabib.maryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD