Comparative study of the effect of irrigation- suction system with 2% lidocaine during surgery on the reduction of postoperative pain in patients undergoing laparoscopic cholecystectomy in 1999
Evaluation of the effect of irrigation suction system with 2% lidocaine combination during surgery on reducing postoperative pain in patients undergoing laparoscopic cholecystectomy in 1399
Design
This study is a clinical trial. The study population consisted of 70 patients with cholecystitis who referred to treatment of their disease for cholecystectomy.
The patient and the person evaluating the amount of pain and analyzing the data are unaware of the patient's treatment group and the study is a three-blind study.
Settings and conduct
The researcher goes to the hospital on different days and according to the patients' actions, from the list of hospitalized patients, first gives them the reason for doing this plan and other necessary explanations, and then, if the patients wish, interviews them. In terms of anonymity, participants will be reassured at all stages of the research, as well as when the data is published, and participants will be allowed to leave the study at any time
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- All patients with chronic cholecystitis are candidates for elective laparoscopic cholecystectomy
The age of the patient should not be less than 20 and not more than 60
Exclusion criteria:
- Taking drugs that can be effective on postoperative pain in patients
- History of drug or alcohol use (now or in the past)
Existence of acute gallbladder and acute cystitis
Existence of severe inflammation and adhesions at the site of surgery so that open surgery is required
Gallbladder rupture and bile leakage at the operation site
Bleeding during surgery so that there is a possibility of peritoneal stimulation due to blood in the peritoneum
Intervention groups
Patients undergoing laparoscopic cholecystectomy
Main outcome variables
the patient's pain intensity and the number of days the patient stays in the hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201006048950N1
Registration date:2020-12-08, 1399/09/18
Registration timing:prospective
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Mahboobeh Khosravani
Name of organization / entity
Arakuniversity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
mahboobkhosravani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-21, 1399/12/03
Expected recruitment end date
2021-07-25, 1400/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of irrigation- suction system with 2% lidocaine during surgery on the reduction of postoperative pain in patients undergoing laparoscopic cholecystectomy in 1999
Public title
effect of irrigation- suction system on the reduction of postoperative pain in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic cholecystitis are candidates for elective laparoscopic cholecystectomy
Exclusion criteria:
Taking medications that can affect patients' postoperative pain
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after obtaining patient satisfaction, using random permutation block method, patients were randomly assigned to two groups of suction-irrigation with normal saline composition of 0.9% and suction irrigation with lidocaine combination of 2%.
First, the name of each suction-irrigation method is an English letter such as A and B, and the randomization list will be a sequence of these two letters. Therefore, the person making the list is not aware of the method.
In the random permutation block method, double blocks AB and BA are used. Randomization unit is a block.
The lead researcher who conducts the study is only aware of the next patient's treatment and proceeds accordingly.
Finally, 35 people are examined in each group, which includes a total of 70 patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is of the one-blind type. The patient is fully aware that he or she has participated in a study with two methods of suction irrigation and completes the informed consent form. But the patient does not know which irrigation suction method was used for him. Therefore, the patient is blinded.The lead researcher and her colleagues could not be blinded due to the implementation of irrigation suction methods
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Scienses, Dr Qarib Blvd., Basij Sq, Arak City
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.ARAKMU.REC.1399.210
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K80.0
ICD-10 code description
cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
0, 6, 12, 24 hours after surgery
Method of measurement
10 point pain ruler/ Select descriptive smileys
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Used 2%Lidocaine And 0.9%Sodium Chloride Serum : In the intervention group, the operation locale was Irrigated with 100 cc of 0.9% normal saline solution containing 2 mg / kg 2% lidocaine for 5-10 minutes and then the entire fluid was aspirated by the Suction-Irrigation Device as much as possible.
Category
Treatment - Drugs
2
Description
Control group: Just used 0.9%Sodium Chloride Serum
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr (A.s) Education and Treatment Center
Full name of responsible person
Abolfazl Mohtarami
Street address
Vali-Asr (A.s) Education and Treatment Center, Vali-Asr Sq, Arak city
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Amir-al-Momenin(A.S) Education and Treatment Center
Full name of responsible person
Abolfazl Mohtarami
Street address
Basij Sq, Dr Qarib Blvd
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Sq
City
Arak
Province
Markazi
Postal code
۶۹۴۱-۷-۳۸۴۸۱
Phone
+98 86 3417 3524
Email
amoozesh@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Abolfazl Mohtarami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Basij Sq
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
daneshkadeha@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square,sardasht street.medical university of arak.faculth of nursing.
City
Markazi
Province
Markazi
Postal code
۶۹۴۱-۷-۳۸۴۸۱
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
mahboobkhosravani@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square,sardasht street.medical university of arak.faculth of nursing.
City
Markazi
Province
Markazi
Postal code
۶۹۴۱-۷-۳۸۴۸۱
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
mahboobkhosravani@arakmu.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available