Protocol summary
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Study aim
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comparative study of the effect of analgesia of preemptive and postoperative Transversalis Abdominis plane block under ultrasound guidance in patients undergoing elective laparoscopic Cholecystestomy.
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Design
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This study is a single blind clinical trial in which the number of patients is determined according to the sample size formula and a simple randomization method is used, and using a table of random numbers, patients are assigned to two treatment groups. The sample size in this study is 76 patients, which are divided into two groups of 38.
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Settings and conduct
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This study is performed in Rasoul Akram Hospital in Tehran and after obtaining patient satisfaction and approval of the ethics committee, patients are randomly divided into two groups. In the first group, After anesthetizing the patient, the Transverse Abdominis block is performed with Ropivacaine before performing laparoscopic cholecystectomy, and in the second group, sensory block is performed after the Surgery.This study is single blind and the person analyzing the information is unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients aged 20-60 years under Laparoscopic Cholecystectomy, Patients with ASA 1 & 2 anesthesia score Exclusion criteria:History of Rupivacaine allergy, Patients with BMI> 40, Emergency patients
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Intervention groups
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After patient satisfaction and the approval of the ethics committee, patients are randomly divided into two groups. In the first group, the patient is first anesthetized, and then the Transverse Abdominis block is performed with Ropivacaine before performing Laparoscopic cholecystectomy, and in the second group, Regional block is performed after the Surgery.
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Main outcome variables
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Pain, Nausea, Vomiting
General information
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Reason for update
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The sample size written (58 patients: 29 in each group) is not correct and in fact 76 patients and 38 patients in each group is correct.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120814010599N26
Registration date:
2020-05-31, 1399/03/11
Registration timing:
prospective
Last update:
2021-09-09, 1400/06/18
Update count:
2
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Registration date
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2020-05-31, 1399/03/11
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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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2020-06-20, 1399/03/31
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Expected recruitment end date
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2021-01-18, 1399/10/29
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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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comparative study of the effect of analgesia of preemptive and postoperative Transversalis Abdominis plane block under ultrasound guidance in patients undergoing elective laparoscopic Cholecystestomy.
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Public title
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Comparison of regional anesthesia on pain control in Cholecystectomy surgery with two methods before and after surgery.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients aged 20-60 years under Laparoscopic Cholecystectomy
Patients with ASA 1 & 2 Anesthesia score
Exclusion criteria:
History of Rupivacaine allergy.
Patients with BMI> 40.
Emergency patients
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Age
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From 20 years old to 60 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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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For randomization, a simple randomization method is used, which is done using a table of random numbers.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain numbers for each group (for example, even numbers for intervention A and odd numbers for intervention B).Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups.
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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 person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B.
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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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2020-02-03, 1398/11/14
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Ethics committee reference number
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IR.IUMS.FMD.REC.1398.484
Health conditions studied
1
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Description of health condition studied
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Cholecystectomy
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ICD-10 code
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K91.86
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ICD-10 code description
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Retained cholelithiasis following cholecystectomy
Primary outcomes
1
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Description
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Pain
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Timepoint
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After surgery
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Method of measurement
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Pain questionnaire
Secondary outcomes
1
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Description
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Nausea
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Timepoint
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After surgery
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Method of measurement
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Self-report by the patient and recorded in the questionnaire
2
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Description
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Vomiting
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Timepoint
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After surgery
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Method of measurement
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Self-report by the patient and recorded in the questionnaire
Intervention groups
1
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Description
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Intervention group: In the first group, after induction of general anesthesia and in sterile conditions in the supine position (SUPINE) with linear probe of ultrasound (SonoSite made in USA) and with sterile syringe with 20 cc of Ropivacaine 0.25% in each part (Ropivacaine maylan made in france) and with Spinal needles No. 23 (dr japan) are blocked.
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Category
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Treatment - Devices
2
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Description
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Intervention group: In the second group, after the end of the surgery and before the patient's extubation and in sterile conditions in the supine position (SUPINE) with linear probe of ultrasound (SonoSite made in USA) and with sterile syringe with 20 cc of Ropivacaine 0.25% in each part (Ropivacaine maylan made in france) and with Spinal needles No. 23 (dr japan) are blocked.
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Category
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Treatment - Devices
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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available