Determination of the ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
Design
Clinical trial, with tow parallel groups, single blind, accidental with number of samples 62 and 31 sample in each group.
Settings and conduct
After selection of the patient, getting satisfaction, and monitoring in the recovery unit, the patient is positioned left laterally, the right side is prep and drep, the probe of sonography is located longitudinally at the level of T7 (lower border of scapula) and after determination the lower and upper transverse processes, the needle is inserted in plane toward the erector spinae plane muscle. 20 cc Ropivacaine 0/2% is injected into the fascia of erector spinae plane muscle (behind the transverse process). A PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram /1 cc) is connected to patient in both groups. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl). In the control group only the aforementioned pomp with the same setting and contents is inserted.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with ASA =< 2
patients with the age of 20-65 years old
Exclusion criteria: Emergent patients, History of allergy to Ropivacain,
analgesic consumption during the last 24 hours, BMI > 35
liver disease, renal disease and coagulopathy, Changing the plan of the surgery to the open cholecystectomy, occurrence of any problem during the operation
Intervention groups
Investigation of the ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
Main outcome variables
Degree of the pain in rest mood and coughing after the surgery during the specific time intervals
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120814010599N25
Registration date:2020-01-24, 1398/11/04
Registration timing:prospective
Last update:2020-01-24, 1398/11/04
Update count:1
Registration date
2020-01-24, 1398/11/04
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
2020-02-01, 1398/11/12
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
Public title
Effect of the ultrasound-guided erector spinae plane block on the degree of post laparoscopic cholecystectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with ASA =< 2
patients with the age of 20-65 years old under laparoscopic cholecystectomy
Exclusion criteria:
Emergent patients
History of allergy to Ropivacain
Patients received analgesic during the last 24 hours
Patients with BMI > 35
Patients with liver disease, renal disease and coagulopathy or a history of it
Changing the plan of the surgery from the laparoscopy to the open cholecystectomy or occurrence of any problem during the operation
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a single-blind technique in which the person recording the information has no idea regarding the control or case group is used.
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
Vice-chancellor for research and technology of Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.IUMS.FMD.REC.1397.287
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
The amount of the opioid used during the first 24 hours after the surgery in milligrams.
Timepoint
0 means at the time of arrival to the recovery, 20 minutes after the implementation of the block, 2, 4, 6, 12, and 24 hours after the surgery.
Method of measurement
Based on the amount of the used opioid reported by the person recording the information in the questionnaire in milligrams
Secondary outcomes
1
Description
The degree of the pain based on the Numerical Rating Scale criterion
Timepoint
0 means at the time of arrival to the recovery, 20 minutes after the implementation of the block, 2, 4, 6, 12, and 24 hours after the surgery
Method of measurement
The degree of the pain based on the Numerical Rating Scale criterion
Intervention groups
1
Description
Intervention group:After the operation, upon arrival the patient to the recovery unit and monitoring, the patient is positioned left laterally, the right side is prep and drep, the probe of sonography is located longitudinally at the level of T7 (lower border of scapula) and after determination the lower and upper transverse processes, the needle is inserted in plane toward the erector spinae plane muscle. 20 cc Ropivacaine 0/2% is injected into the fascia of erector spinae plane muscle (behind the transverse process). A PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient in both groups. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl).
Category
Treatment - Other
2
Description
Control group: After the operation, upon arrival the patient to the recovery unit and monitoring, a PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr. Poupak Rahimzadeh
Street address
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2493
Email
p-rahimzadeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Poupak Rahimzadeh
Street address
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2493
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
Dr. Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
02164352493
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
Dr. Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2493
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
Dr. Poupak Rahimzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2493
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