Comparison of the effect of spinae plane block and retrolaminar block,under ultrasound guidance, on pain after laparoscopic upper abdominal surgery
Design
Clinical trial with control group, with parallel groups, double blinded, randomized, phase 3
Settings and conduct
In this clinical trial study, 70 patients who were candidates for upper abdominal laparoscopic elective surgery referred to Rasoul-e-Akram and Firoozgar hospitals were randomly divided into two groups. In this case, the patient and the statistical analyzer are blind and the main outcome is pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients' consent to enter the study, Patients with ASA <1 & 2, Patients aged 20-60 yearsو Patients undergoing upper abdominal laparoscopic surgery. Exclusion criteria:Emergency patient, History of ropivacaine allergyو Patients who have received analgesia in a recent dayو Patients with a Body mass index >35.و Patients with or underlying liver and kidney disease and coagulopathy, Patients addicted to opioids
Intervention groups
Intervention group 1: spinae plane erector block under ultrasound guidance
Intervention Group 2: Retrolaminar block under ultrasound guidance
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120814010599N28
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-22, 1400/02/02
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spinae plane block and retrolaminar block,under ultrasound guidance, on pain after laparoscopic upper abdominal surgery
Public title
The effect of spinae plane block and retrolaminar block on pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' consent to enter the study
Patients with ASA <1 & 2
Patients aged 20-60 years
Patients undergoing upper abdominal laparoscopic surgery
Exclusion criteria:
Emergency patients
History of ropiavacaine allergy
Patients who have received analgesia in a recent day
Patients with a Body Mass Index>35
Patients with or underlying liver and kidney disease and coagulopathy
Patients addicted to opioids
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients, using random allocation software, were randomly divided into spinae plane block and retrolaminar block groups. By entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers. If we enter the number "70" in this software, it generates 35 "Control " names and 35 "Intervention" names, which are randomly distributed and presented as a list. Patients are grouped according to this list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the statistical analyzer were unaware that the patient was exposed to the spinae plane block and retrolaminar block methods. Blocking was performed by an anesthesiologist in the operating room for randomly selected patients before the operation under general anesthesia. The groups are provided to the statistical analyzer in the form of codes A and B for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.IUMS.FMD.REC.1399.495
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
After the end of surgery and 20 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery
Method of measurement
Using Numeric Rating Scale (NRS)
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
After the end of surgery and twenty minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after surgery
Method of measurement
poor:0,moderate:1,good:2,very good:3,excellent:4
Intervention groups
1
Description
Intervention group:In the group that intends to perform the Spinae plain erector block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after specifying the border of the transducer of the upper and lower lobe processes, the needle enters the skin and subcutaneous tissue In Plane and is directed to the erector muscle of the spinae plain. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected into the muscle fascia of the erector spinae plain (behind the process transducer).
Category
Treatment - Drugs
2
Description
Control group:In the group that intends to perform the retrolaminar block, the patients are placed in the lateral position after monitoring, and on the surgical side after prep and drape, the curve ultrasound probe is located longitudinally at the T7 vertebrae (process transducer) (Lower scapula border) and after determining the lamina of the vertebra and its prickly appendage, we insert the needle 1 to 1.5 cm laterally into the prickly appendage and move towards the caudal or cranial to reach the vertebral lamina.. A volume of 20 cc of 0.1% ropivacaine (made by Cobel company) is injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh “St.”,Sattarkahn “Ave.”, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Email
poupak_rah@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abas Motavalian
Street address
Shahid Hemmat Expway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Email
poupak_rah@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
p-rahimzadeh@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available