Determining the effect of lateral position after spinal anesthesia on the need for postoperative narcotics
Design
Clinical trial with intervention and control groups, 69 patients sample size, Trial phase 2-3. Simple randomization will be done as a block randomization method.
Settings and conduct
69 participants with entry conditions, among the candidates for percutaneous nephrolithotomy surgery referred to Shahid Labafinejad Hospital in 2022, were randomly divided into two control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 and above; Candidate patients for percutaneous nephrolithotomy surgery; Candidate for spinal anesthesia; Patients with satisfaction to participate in the study
Exclusion criteria: History of neurological diseases; diabetes; hypertension; History of drug and alcohol abuse; History of vascular disorders in the lower limbs; History of spine surgery; History of psychiatric diseases and psychological disorders; Patients dissatisfied with participation in the study
Intervention groups
Intervention group: After spinal anesthesia, they undergo percutaneous nephrolithotomy surgery in the lateral position.
Control group: After spinal anesthesia, they undergo percutaneous nephrolithotomy in supine position.
Main outcome variables
The amount of narcotic needed after the operation; the first time of narcotic consumption; hemodynamics of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056450N1
Registration date:2023-01-19, 1401/10/29
Registration timing:retrospective
Last update:2023-01-19, 1401/10/29
Update count:0
Registration date
2023-01-19, 1401/10/29
Registrant information
Name
Alireza Jaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2360 2280
Email address
alirezajaffari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-20, 1401/09/29
Expected recruitment end date
2023-01-19, 1401/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lateral position after spinal anesthesia on the need for postoperative narcotics
Public title
The effect of lateral position after spinal anesthesia on the consumption of narcotic drugs after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Candidate patients for percutaneous nephrolithotomy surgery
Candidate for spinal anesthesia
Patients with satisfaction to participate in the study
Exclusion criteria:
History of neurological diseases, diabetes, hypertension
History of drug and alcohol abuse
History of vascular disorders in the lower limbs
History of spine surgery
History of psychiatric diseases and psychological disorders
Patients dissatisfied with participation in the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done as a block randomization method. So, initially, in the Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB). (AB, AB), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is the confirmation of the treatment or intervention group and B is the confirmation of the control group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to the treatment or control groups. The random process of selecting blocks and assigning people to the intervention and control groups will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Not 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
Street address
Tabnak Street.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-08-22, 1398/05/31
Ethics committee reference number
IR.SBMU.MSP.REC.1398.431
Health conditions studied
1
Description of health condition studied
Complications of spinal anesthesia
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia.
Primary outcomes
1
Description
Pain level
Timepoint
15, 30, 45, 60, 95, 105 and 120 minutes after the surgery