Evaluation of the effect of local injection of dexamethasone with bupivacaine at pre-peritoneal laparoscopic ports on laparoscopic complications after laparoscopic cholecystectomy a randomized controlled clinical trial.
Study the effect of dexamethasone and bupivacaine pre-peritoneal injection at the site of laparoscopic ports, on complications after laparoscopic cholecystectomy in Isfahan in 1400
Design
Clinical trial, with control group, with parallel groups, three-way blind, randomized, phase 3 on 96 patients. Random numbers method which carried out at an external site (miraclesalad) is used for randomization.
Settings and conduct
In order to evaluate the effect of bupivacaine with and without dexamethasone on pain after laparoscopic cholecystectomy in the operating room by one of the trained technicians without informing patients and surgeon and researcher in one group bupivacaine + dexamethasone injection and in the other group bupivacaine It is performed alone and in the first 24 hours, the amount of pain and the need for pain in patients is evaluated.
Participants/Inclusion and exclusion criteria
The inclusion criteria is all the patients undergoing laparoscopic cholecystectomy with a diagnosis of biliary colic or chronic cholecystitis in 1400. Criteria for not including patients in our study are: diagnosis of acute cholecystitis along with findings such as, leukocytosis and high ESR and CRP, gangrene, empyema and evidence of bile in the abdominal cavity during surgery, known allergy to local anesthetics, open surgery and diabetic patients and those with dirty wounds and open cholecystectomy.
Intervention groups
7 mg bupivacaine is injected at the lower ports and 3 mg bupivacaine at the upper ports. Then, only in the "bupivacaine + dexamethasone" group, the dose of dexamethasone is determined based on the patient's weight at 0.2 mg per kg and is divided into four parts, and each part is injected at the site of a port.
Main outcome variables
Frequency of nausea and vomiting, relative pain intensity, mean of drug use and mean of BS after 24 hours in the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211008052699N1
Registration date:2021-11-29, 1400/09/08
Registration timing:registered_while_recruiting
Last update:2021-11-29, 1400/09/08
Update count:1
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Mohammad Eslamian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
mr.esl67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local injection of dexamethasone with bupivacaine at pre-peritoneal laparoscopic ports on laparoscopic complications after laparoscopic cholecystectomy a randomized controlled clinical trial.
Public title
Evaluation of dexamethasone injection on complications after gallbladder surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Laparoscopic cholecystectomy with diagnosis of biliary colic or chronic cholecystitis
Exclusion criteria:
Acute cholecystitis
Presence of leukocytosis or high ESR, CRP
Gangrene, empyema and evidence of bile in the abdominal cavity during surgery
Known allergies to local anesthetics
History of chronic pain following the use of common narcotics
Open cholecystectomy
Patients with immunodeficiency and diabetes
Cases that have dirty wounds during the operation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups using computer random number method. This random distribution of patients will be done by an independent computer programmer using www.randomization.com.
Blinding (investigator's opinion)
Triple blinded
Blinding description
On the day of surgery, one of the operating room technicians trained according to the instructions and based on the site www.randomization.com prepares the medicine for the group in which the patient is accidentally placed and then the surgeon injects it only without notice to the relevant place. Dexamethasone and bupivacaine are injected into a syringe, and to hide the volume of the drug, the syringes are covered with a dark coating and the syringe is identified only based on groups A and B. Slowly The patient and the data collector and the safety and data monitoring committee also do not know what the drug was.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences., Hezarjarib St., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-03, 1400/07/11
Ethics committee reference number
IR.MUI.MED.REC.1400.546
Health conditions studied
1
Description of health condition studied
Chronic cholecystitis
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
2
Description of health condition studied
Postprocedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain intensity based on VAS the first 24 hours after surgery
Timepoint
24 hours after the surgery
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
The need for drugs and analgesics
Timepoint
24 hours after the surgery
Method of measurement
Medical records
2
Description
Frequency of nausea, vomiting and diabetes in the patient within 24 hours after surgery
Timepoint
24 hours after the surgery
Method of measurement
Medical records
Intervention groups
1
Description
Intervention group1: After induction of general anesthesia and surgery, a peritoneal injection will be performed at the incision site of the trochanter under the direct guidance of a laparoscopic camera with Branol 18. In the "bupivacaine + dexamethasone" group, 7 mg bupivacaine is injected at the lower ports and 3 mg bupivacaine at the upper ports. The dose of dexamethasone is then determined based on the patient's weight at 0.2 mg per kg and divided into four parts and each part is injected at the site of a port.
Category
Prevention
2
Description
Intervention group2:In the bupivacaine group alone, 7 mg bupivacaine will be injected at the lower ports and 3 mg bupivacaine at the upper ports.:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Hamid Melali
Street address
Sonbolestan St, Ebn-Sina Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5051
Email
dean@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Mohammad Rezavanian
Street address
Soffe Blv
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
3
Recruitment center
Name of recruitment center
Seyyed-al-shohada hospital
Full name of responsible person
Maryam Haghighat
Street address
Motahari Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0210
Email
dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
N. 4, Isfahan university oh medical science, Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 8663 8318
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Soffeh Blvd, Al-Zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
mr.esl67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Soffeh Blvd, Al-Zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
mr.esl67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Soffeh Blvd, Al-Zahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
mr.esl67@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available