Comparison of median and Para median methods in the incidence of Post-Dural-puncture headache in patients undergoing Orthopedic Lower Limb Surgery by spinal anesthesia
Comparison of median and Para median methods in the incidence of PDPH in patients undergoing Orthopedic Lower Limb Surgery
Design
This study will be a double-blind randomized clinical trial with Parallel groups on 60 patients referred to Peymaniyeh Hospital in Jahrom who are undergoing orthopedic lower limb surgery. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Peymaniyeh Hospital in Jahrom who will undergo orthopedic surgery of the lower extremities will be included in the study. Patients participating in the study will be divided into two groups, Madin and Paramedin, by tossing coins. The study participant, researcher, and data collector will be unaware of the type of drug being used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Peymaniyeh Hospital in Jahrom who underwent lower limb orthopedic surgery and expressed their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group 1: Spinal anesthesia in the sitting position of the arachnoid will be performed using a crowford needle with a high gauge 'number' 25 by the median method. Intervention group 2: Spinal anesthesia will be performed using a crowford needle with high gauge 'number' 25 by paramedic method.
Main outcome variables
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N3
Registration date:2021-06-07, 1400/03/17
Registration timing:prospective
Last update:2021-06-07, 1400/03/17
Update count:0
Registration date
2021-06-07, 1400/03/17
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of median and Para median methods in the incidence of Post-Dural-puncture headache in patients undergoing Orthopedic Lower Limb Surgery by spinal anesthesia
Public title
Comparison of median and Para median methods in the incidence of Post-Dural-puncture headache in patients undergoing Orthopedic Lower Limb Surgery by spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People who will be operated with spinal anesthesia.
Hemodynamic stability
Exclusion criteria:
Chronic pain and cancer
Anxiety and mental illness
Infection at the site of needle entry
Coagulation disorders
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study will be divided into two groups, Median and Paramedian, by tossing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used so that the participant in the study, the researcher and the data collector are not aware of the spinal anesthesia method used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.JUMS.REC.1398.102
Health conditions studied
1
Description of health condition studied
Orthopedic patients
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
Headache
Timepoint
Up to 7 days after surgery
Method of measurement
Post-Dural-puncture headache criteria
Secondary outcomes
1
Description
Vital signs
Timepoint
Before spinal anesthesia, after spinal anesthesia and at 5, 15 and 30, 45, 60 and 90 minutes during surgery and in recovery
Method of measurement
Monitoring device
Intervention groups
1
Description
Intervention group 1: Spinal anesthesia in sitting position and in L3-L4 space after washing the place with betadine and alcohol and topical injection of 1 ml of 2% lidocaine and then injection of anesthetic (bupivacaine. 5% CC 12.5 mg) in 5 seconds in space The subarachnoid will be performed us
Category
Treatment - Other
2
Description
Intervention group 2: Spinal anesthesia in sitting position and in L3-L4 space after washing the place with betadine and alcohol and topical injection of 1 ml of 2% lidocaine and then injection of anesthetic (bupivacaine. 5% CC 12.5 mg) in 5 seconds in space The subarachnoid will be performed using a crowford needle with a high gauge 'number' of 25 by the paramedic method.