Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods interpersonal instillation of normal saline, ropivacaine, sodium bicarbonate and ropivacaine-sodium bicarbonate combination
Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods of intraperitoneal instillation of normal saline, ropivacaine, sodium bicarbonate, and ropivacaine-sodium bicarbonate combination.
Design
An interventional and factorial (or replacement) study will be conducted in four groups of 50 with a sample size of 200, double-blind and randomized in completely separate groups.
Settings and conduct
In this study, 200 patients in 4 groups of 50 will be subjected to laparoscopic cholecystectomy in Shahid Faqihi and Abu Ali Sinai hospitals in Shiraz by the double-blind clinical trial method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Patients aged 18 to 60 are candidates for laparoscopic cholecystectomy. Exclusion criteria: history of heart diseases; High and low blood pressure; Bradycardia; 1st, 2nd, 3rd-degree heart block; Patients who use adrenoceptor agonist and antagonist drugs.
Intervention groups
Intervention group1:(A )will receive a dose of 10 ml of ropivacaine 0.5% (Made by Fresenius Kabi, Austria)in the areas below the right and left diaphragm and in the gallbladder, and intervention group 2: (B )will receive a dose of 10 ml of ropivacaine 0.5% along with sodium bicarbonate solution. With a dose of 50 ml, they will receive 7.5% in 1000 ml of normal saline at 37C. Intervention group 3: ( C) will undergo intraperitoneal washing with 7.5% sodium bicarbonate solution and normal saline. Intervention group 4 (control group) (D) will be subjected to intraperitoneal washing with normal saline solution in 1000 ml.
Main outcome variables
post-operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N7
Registration date:2022-09-07, 1401/06/16
Registration timing:prospective
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods interpersonal instillation of normal saline, ropivacaine, sodium bicarbonate and ropivacaine-sodium bicarbonate combination
Public title
Laparoscopic cholecystectomy Postoperative pain relief study by comparing four methods interpersonal instillation of normal saline, ropivacaine, sodium bicarbonate and ropivacaine-sodium bicarbonate combination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
People aged 18 to 60 are eligible candidates for laparoscopic cholecystectomy surgery
Exclusion criteria:
History of heart diseases
Hypertension
Bradycardia
Simultaneous presence of peripheral neuropathy
pregnant women
Patients who are addicted to drugs and stimulants
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 200 patients were randomly divided into 25 blocks with a size of 8 for four groups using the permutation random block method. Blocking and allocating the sequence will be done to hide it by a person not involved in the research, employing identical non-transparent envelopes. Then, based on the obtained blocks and in the order of the allocation sequence, the drugs will be given to the patients. This study is double-blind. Total sample size = number of groups * repetition of the number of groups in each block * number of blocks
And it has been blocked through the following site:https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, The drugs are prepared by an anesthetist who is unaware of how the study is conducted and delivered to the anesthesiologist in the operating room, who is also unaware of how the study is completed. In this way, the patient, the anesthesia resident, and the person who prepares the medicine are not aware of the study group's allocation and are blinded to the study.
Placebo
Not used
Assignment
Factorial
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
7134814336
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
IR.SUMS.MED.REC.1400.569
Health conditions studied
1
Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K82.9
ICD-10 code description
Disease of gallbladder, unspecified
Primary outcomes
1
Description
Postoperative pain
Timepoint
Times 0-1-2-4-8-12 and 24 hours after the operation
Method of measurement
VAS (Visual Analog Scale) & VRS(Verbal Rating Scale) numerical scoring scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: group A patients; will receive 10 ml of ropivacaine 0.5% (Made by the company Fresenius Kabi, Austria) in the areas below the right and left diaphragm and in the gallbladder bed.
Category
Treatment - Surgery
2
Description
Intervention group2: In group B, they will receive ropivacaine 0.5 with a dose of 10 ml along with sodium bicarbonate solution(Made by Sopa company Iran) with a dose of 50 ml of 7.5% in 1000 ml of normal saline at a temperature of 37 degrees Celsius.
Category
Treatment - Surgery
3
Description
Intervention group3: In group C patients, sodium bicarbonate solution with a dose of 50 ml of sodium bicarbonate 7.5 in 1000 ml of normal saline at 37 degrees Celsius for 2 to 5 minutes is used to wash the abdomen, and after 5 minutes the liquid will be suctioned.
Category
Treatment - Surgery
4
Description
Intervention group4: Group D, which will undergo intraperitoneal washing with normal saline solution in the amount of 1000 ml alone.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faqhihi Hospital
Full name of responsible person
Mina Bazrafkan
Street address
Shiraz - Karim Khan Zand Blvd. - next to medical school
City
SHIRAZ
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
FaghihiHsp@Sums.ac.ir
2
Recruitment center
Name of recruitment center
Abu-Alisiana Hospital
Full name of responsible person
Mina Bazrafkan
Street address
Shahr-e jadid-e sadra, Sadra Hwy,
City
SHIRAZ
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Email
abualisinacharity@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mahtab Memarpoor
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
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
memarpour@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
Asghar Rayat zade
Position
Anesthesiology resident/physician
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
Fax
+98 71 3628 1506
Email
dr.rayat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Eghbal
Position
Anesthesiology of Transplantation
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
mheghbal@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MaryamTabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
SHIRAZ
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3628 1506
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
It is against our policy.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available