Comparison study of continuous serratous anterior plane block and thoracic epidural block in post thoracotomy analgesia
Design
Clinical trial with intervention and control groups,40 patients sample size, Trial phase 2-3.Simple randomization based on random numbers table.
Settings and conduct
40 participants who meet inclusion criteria among candidates referred to the Masih Daneshvari hospital in 2019 were divided to continuous anterior serratus block or epidural thoracic continuous block.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for continuous anterior serratus block / persistent thoracic epidural block; Age 18 and above; Patients with satisfaction to participate in the study
Exclusion criteria: Contraindication of any continuous anterior / epidural thoracic continuous block; Chronic thoracic pain; Drug and Alcohol Abuse; Coagulopathy; Patients dissatisfied with participation in the study
Intervention groups
Intervention group: The ultrasound probe is placed in the midclavicular region of the chest at the sagittal surface. After determining the fifth midaxillary rib, the needle is inserted to a depth of 1–2 cm. After fixation of the epidural catheter in the anterior of the serratus muscle, first 10 ml of 0.25% marcain is injected and then 5 ml of solution contains 0.1% marcine is infused.
Control group: The epidural catheter is fixed in the T7-8 space. The injectable drugs are similar to the intervention group.
Main outcome variables
Pain Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015515N9
Registration date:2019-10-27, 1398/08/05
Registration timing:registered_while_recruiting
Last update:2019-10-27, 1398/08/05
Update count:0
Registration date
2019-10-27, 1398/08/05
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
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of continuous serratous anterior plane block and thoracic epidural block in post thoracotomy analgesia
Public title
Comparison of postoperative thoracotomy analgesia with continuous serratus block and epidural thoracic block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Patients candidate for continuous anterior serratus block / persistent thoracic epidural block
Patients with satisfaction to participate in the study
Exclusion criteria:
Contraindication of any continuous anterior / epidural thoracic continuous block
Chronic thoracic pain
Drug and Alcohol Abuse
Coagulopathy
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on random numbers table. In this way, we put a set of numbers in a completely random order without any pattern or order, set the table numbers to read from above. For intervention group we consider even numbers and for control group we consider individual numbers. Then we place one of the numbers up and down, register the number and assign it to one of the intervention or control groups.
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 St.,Tehran, Tehran, Iran, Islamic Republic Of
Intervention group: The ultrasound probe is placed in the midclavicular region of the chest at the sagittal surface. After determining the fifth midaxillary rib, the needle is inserted to a depth of 1–2 cm. After fixation of the epidural catheter in the anterior of the serratus muscle, first 10 ml of 0.25% marcain is injected and then 5 ml of solution contains 0.1% marcine is infused.
Category
Treatment - Devices
2
Description
Control group: The epidural catheter is placed in the T7-8 space. The injectable drugs are similar to the intervention group.