Protocol summary
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Study aim
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Determination of the ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
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Design
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Clinical trial, with tow parallel groups, single blind, accidental with number of samples 62 and 31 sample in each group.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Investigation of the ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
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Main outcome variables
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Degree of the pain in rest mood and coughing after the surgery during the specific time intervals
General information
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Reason for update
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In the design section, a randomized study was mentioned, but in the randomization section, "non-randomized" was mentioned, which was corrected. Also a secondary outcome was the administration of meperidine, which was corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120814010599N25
Registration date:
2020-01-24, 1398/11/04
Registration timing:
prospective
Last update:
2022-03-26, 1401/01/06
Update count:
1
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Registration date
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2020-01-24, 1398/11/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-01, 1398/11/12
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Expected recruitment end date
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2020-08-31, 1399/06/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigation of the Ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain
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Public title
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Effect of the ultrasound-guided erector spinae plane block on the degree of post laparoscopic cholecystectomy pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
62
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 15 blocks and also one block of 2 patients (Totally 62 patients). Then, within each block, subjects will be randomly assigned to intervention or control group . Random assignment will be done using a random number table
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-23, 1397/10/02
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Ethics committee reference number
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IR.IUMS.FMD.REC.1397.287
Health conditions studied
1
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Description of health condition studied
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Laparoscopic cholecystectomy
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ICD-10 code
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K80.0
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ICD-10 code description
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Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
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Description
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The degree of the pain based on the Numerical Rating Scale criterion
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Timepoint
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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
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Method of measurement
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The degree of the pain based on the Numerical Rating Scale criterion
Secondary outcomes
1
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Description
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The amount of the opioid used during the first 24 hours after the surgery in milligrams
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Timepoint
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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.
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Method of measurement
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Based on the amount of the used opioid reported by the person recording the information in the questionnaire in milligrams
Intervention groups
1
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Description
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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).
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Category
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Treatment - Other
2
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Description
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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).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable