Comparison of the incidence of low back pain after spinal anesthesia by Madin and Paramedin methods in non-pregnant women undergoing short-term surgery in Bouali Hospital in 1399-1400
Design
Two-group, double-blind, randomized, on 106 patients
Settings and conduct
This study is performed on 106 non-pregnant women referred to Bu Ali Hospital in the years 1300-1400 who are candidates for short-term surgery. 53 of them undergo median method and 53 patients undergo paramedin method under spinal anesthesia. After surgery and recovery in four stages (after recovery and after transfer to the ward every 6 hours) for low back pain They are evaluated. After discharge, the patient is examined for back pain for 4 weeks and once a week during a telephone call. This evaluation is done through Visual Analog Scale. Then the amount of pain for each person in the questionnaire Relevant is registered.
Participants/Inclusion and exclusion criteria
Obtaining informed consent; Women 18 to 68 years old; ASA Class 1 and 2; No history of spinal surgery; - No contraindication to SA; No history of back pain and headache in previous SAs; No history of any previous severe non-traumatic low back pain; No serious trauma to the spine; Lack of emergency surgery
Intervention groups
Intervention group 1: undergoing spinal anesthesia by median method. Intervention group 2: undergoing paramedin
Main outcome variables
Intensity back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210930052642N1
Registration date:2021-10-27, 1400/08/05
Registration timing:registered_while_recruiting
Last update:2021-10-27, 1400/08/05
Update count:0
Registration date
2021-10-27, 1400/08/05
Registrant information
Name
ali shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7774 2599
Email address
alish9574@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-08, 1400/07/16
Expected recruitment end date
2021-12-29, 1400/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
incidence of low back pain after spinal anesthesia by Madin and Paramedin methods in non-pregnant women undergoing short-term surgery
Public title
incidence of low back pain after spinal anesthesia by Madin and Paramedin methods in non-pregnant women undergoing short-term surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent
Women 18 to 68 years old
ASA Class 1 and 2
Exclusion criteria:
Age
From 18 years old to 68 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization: A simple random method will be divided into intervention or control. The tool used will be a random number table. By selecting a number at random and specifying the direction of movement, people will be assigned to the control group if it shows the direction of movement of an even number. If it shows an odd number of people will be given to the intervention group. The output is that people are randomly divided into two equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: Participants in this study were unaware of the type of spinal sensation performed.
Clinical caregivers: The doctors who performed the project did not know that low back pain would be studied in patients undergoing spinal anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences