Comparison of two methods of midline interlaminar and parasagittal interlaminar epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities
Objectives: This study is aimed to comparison of two methods of midline interlaminar and parasagittal interlaminar epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities.
Design: Double blind randomized clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: forty patients, with patient candidate for tibial shaft fracture orthopedic surgery; Tibial fracture, which passed 120-90 minute of it; Age more than 18 yr; ASA Class I- II undergoing orthopedic surgery in the lower extremities in Akhtar Hospital were included. Patients were randomized into two groups of midline interlaminar and parasagittal interlaminar 20 patients .
Intervention: Intervention group , patients received parasagittal interlaminar and control group, midline interlaminar .
Main outcome measures (variables): Sensory block; Motor block; Duration of sensory block; Duration of motor block, Blood pressure; Heart rate; Bradycardia ; Hypotension.
Secondary outcome measures (variables): Nausea; Vomiting; Headache; Bleeding; Urinary retention.
The type of method are coded by individual not aware of the research process.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041615515N2
Registration date:2017-05-02, 1396/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-02, 1396/02/12
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-10, 1395/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of midline interlaminar and parasagittal interlaminar epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities
Public title
Comparison of two methods midline and lateral of epidural anesthesia in patients undergoing orthopedic surgery in the lower extremities
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidate for tibial shaft fracture orthopedic surgery; Tibial fracture, which passed 120-90 minute of it; Age more than 18 yr; ASA Class I- II; Signed written informed consent to participate in the study.
Exclusion criteria:
Pregnant women; Sepsis; Emergency surgeries; Infection at the site of injection; Coagulopathy or other bleeding diathesis; Spinal deformity; Diabetes; Systemic disease and neuropathy; History of surgery on the lumbar spine; Facet joint arthropathy; Cauda equina syndrome and other unstable neurologic deficits; Allergic to contrast or lidocaine.
Age
From 19 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Street address
Tabnak St.
City
Tehran
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
SBMU.REC.1394.22
Health conditions studied
1
Description of health condition studied
Tibial shaft fracture
ICD-10 code
S82.109
ICD-10 code description
Unspecified fracture of upper end of unspecified tibia
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after anesthesia to end of surgery
Method of measurement
mmHg
2
Description
Heart rate
Timepoint
Before and after anesthesia to end of surgery
Method of measurement
bpm
3
Description
Sensory block
Timepoint
After anesthesia to exit of recovery
Method of measurement
Pinprick test
4
Description
Motor Block
Timepoint
After anesthesia to exit of recovery
Method of measurement
Bromage score
5
Description
Duration of sensory block
Timepoint
After anesthesia
Method of measurement
Minute
6
Description
Duration of motor block
Timepoint
After anesthesia
Method of measurement
Minute
7
Description
Bradycardia
Timepoint
After anesthesia to end of surgery
Method of measurement
bpm
8
Description
Hypotension
Timepoint
After anesthesia to end of surgery
Method of measurement
mmHg
Secondary outcomes
1
Description
Nausea
Timepoint
After entering the recovery
Method of measurement
Ask the patient
2
Description
Vomiting
Timepoint
After entering the recovery
Method of measurement
Ask the patient
3
Description
Headache
Timepoint
After entering the recovery
Method of measurement
Ask the patient
4
Description
Bleeding
Timepoint
After entering the recovery
Method of measurement
The amount collected in the drain
5
Description
Urinary retention
Timepoint
After entering the recovery
Method of measurement
Urinary catheter
Intervention groups
1
Description
Intervention group:
Patients received parasagittal interlaminar of epidural anesthesia.
Category
Prevention
2
Description
Control group:
Patients received midline interlaminar of epidural anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Elahiye St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences and Health Services