Comparison between intraperitoneal versus transversus abdominis plane block by ropivacaine for postoperative analgesia in laparoscopic cholecystectomy
Design
Double-Blinded Randomized Clinical Trial
Settings and conduct
68 patients will be compared in two groups of 34 patients in Bualisina transplant hospital and in these two groups, the effect of Transversus abdominis plane block by ropivacaine and intraperitoneal administration of ropivacaine to control postoperative pain in laparoscopic cholecystectomy are compared.
Participants/Inclusion and exclusion criteria
Major inclussion criteria: Patients aged 18 to 65 years with ASA class I & II who are candidates for laparoscopic cholecystectomy exclusion criteria: Allergy to any local anesthetic; Conductive heart diseases that prevent the use of local anesthetics; Patients taking painkillers for other chronic pain; Patients with a history of drug use or alcoholism; BMI> 35; Previous abdominal surgery; Patients who are unable to express pain score for any psychological reason.
Intervention groups
In the first intervention group (group I), 30 ml of 0.2%(Made by Multeni Company) ropivacaine enters the peritoneal space through the trocar. In intervention group 2: (T group) after the end of surgery and before the patient woke up, under the ultrasound guidance transversus abdominis block (TAP block) by an anesthesiologist with 30 ml of ropivacaine 0.2%(Made by Multeni Company) (15 ml per Side) is done.
Main outcome variables
Postoperative pain, The patient's pain is measured, and recorded by the recovery staff based on the VAS criteria or scoring of pain sensation and by the ward staff after discharge from the recovery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043550N4
Registration date:2022-03-06, 1400/12/15
Registration timing:registered_while_recruiting
Last update:2022-03-06, 1400/12/15
Update count:0
Registration date
2022-03-06, 1400/12/15
Registrant information
Name
Ashkan Panah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
panah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-07-16, 1401/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between intraperitoneal versus transversus abdominis plane block by ropivacaine for postoperative analgesia in laparoscopic cholecystectomy
Public title
Comparison between intraperitoneal versus transversus abdominis plane block by ropivacaine for postoperative analgesia in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent
Patient aged 18 to 65 years with ASA class I & II who is a candidate for laparoscopic cholecystectomy
Exclusion criteria:
Conductive heart diseases that prevent the use of local anesthetics.
Patients taking painkillers for other chronic pain
Patients with a history of drug use or alcoholism
BMI> 35
Patients who are unable to express pain score for any psychological reason
Previous abdominal surgery
Allergy to any local anesthetic
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. Samples (68 patients) by random block method with blocks of 4 and 8 including 34 participants in two treatment groups, intervention group 1 with 34 participants and in intervention group 2 Also, with 34 participants, will be identified using a table of random numbers extracted from the relevant software. Matching will be done then based on the obtained blocks and the sequence of drug allocation in the operating room will be injected to the people. This study is a double-blind study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared by an anesthesiologist who does not know how to perform the study and is delivered to the anesthesiologist in the operating room. Recovery will not give them any information and thus the patient, recovery nurse and inpatient ward, and data analyzer will be referred to the blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SUMS.MED.REC.1400.562
Health conditions studied
1
Description of health condition studied
laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
post operative pain
Timepoint
The patient's pain is measured at 0, 2, 4, 8, 12, 18 and 24.
Method of measurement
The patient's pain is measured, and recorded by the recovery staff based on the VAS criteria or scoring of pain sensation and by the ward staff after discharge from the recovery.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (Group I) 30 ml of 0.2% ropivacaine (made by Multeni company) enters the peritoneal space through the trocar
Category
Treatment - Drugs
2
Description
Intervention group:2: (Group T) after the end of surgery and before the patient woke up, under the guidance of ultrasound transversus abdominis block (TAP block) by anesthesia with 30 ml of ropivacaine 0.2% (made by Multeni company) (15 ml in Each side) is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
pooya vatankhah
Street address
Fars Province, Sadra, Sadra Hwy
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Email
abualisinacharity@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab memarpoor
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
+98 71 3647 4270
Phone
+98 71 3484 4119
Email
Vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
paria dinparvar
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3630 4312
Email
pariadin۶۴@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan panah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Khalili st
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶۷۱۳۴۸
Phone
+98 71 3629 1470
Email
panah@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Tabibzadeh
Position
Shiraz University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available