Comparison of the effect of local marcaine (site of ports) with intraperitoneal marcaine on pain after laparoscopic cholecystectomy surgery.
Design
Clinical trial without control group, with parallel groups, one-sided blind, randomized, phase 2-3 on 28 patients, rand function of Excel software was used for randomization.
Settings and conduct
Patients in Aria Hospital of Mashhad will be randomly divided into two groups with the help of sealed envelopes:
Group 1:
Local infiltration (port site) of 20 ml of 0.25% bupivacaine solution at the end of the procedure before closing the wound, which will be 5 ml per port.
Group 2:
After removing the gallbladder, they will receive intraperitoneal infiltration of 20 ml of 0.25% bupivacaine solution in the bed of the gallbladder and under the right dome of the diaphragm.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- Patients undergoing elective laparoscopic head cystectomy surgery
2- Age between 18 and 65 years
Exclusion criteria:
1- The occurrence of unwanted complications during the operation
2- People with contraindications to the prescription of anesthetic drugs or opioids (patients with known hypersensitivity to the compounds of various anesthetic drugs)
Intervention groups
Group 1:
Local infiltration (port site) of 20 ml of 0.25% bupivacaine solution at the end of the procedure before closing the wound, which will be 5 ml per port.
Group 2:
After removing the gallbladder, they will receive intraperitoneal infiltration of 20 ml of 0.25% bupivacaine solution in the bed of the gallbladder and under the right dome of the diaphragm.
Main outcome variables
1- Postoperative pain is different in the two study groups.
2- The amount of additional pain relief after the operation is different in the two study groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058293N1
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Shabnam Shafiee jafarabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 2305
Email address
shbnmshafiee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local marcaine (port location) with intraperitoneal marcaine on painafter laparoscopic cholecystectomy
Public title
Comparison of the effect of local marcaine (port location) with intraperitoneal marcaine on painafter laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective laparoscopic head cystectomy surgery
Age between 18 and 65 years
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups with the help of sealed envelopes
Group 1:
Local infiltration (port site) of 20 ml of 0.25% bupivacaine solution at the end of the procedure before closing the wound, which will be 5 ml per port.
Group 2:
After removing the gallbladder, they will receive intraperitoneal infiltration of 20 ml of 0.25% bupivacaine solution in the bed of the gallbladder and under the right dome of the diaphragm.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted in the form of a two-group, single-blind clinical trial, where the patients will be unaware of the assigned treatment, on patients undergoing elective laparoscopic cephalocystectomy surgery at Aria Hospital in Mashhad.
People with entry criteria and those without exit criteria will enter the study after providing an explanation about the design and completing the informed consent form.
Patients will be randomly divided into two groups with the help of sealed envelopes
Group 1:
Local infiltration (port site) of 20 ml of 0.25% bupivacaine solution at the end of the procedure before closing the wound, which will be 5 ml per port.
Group 2:
After removing the gallbladder, they will receive intraperitoneal infiltration of 20 ml of 0.25% bupivacaine solution in the bed of the gallbladder and under the right dome of the diaphragm.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University, Mashhad.
Street address
Mashhad, Imam Khomeini Boulevard, Bazarche Sarab, between 13 and 15 Bazarche Sarab
City
mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2022-10-01, 1401/07/09
Ethics committee reference number
129.IR.IAU.MSHD.REC.1401
Health conditions studied
1
Description of health condition studied
Comparison of the effect of local marcaine (port location) with intraperitoneal marcaine on painafter laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain after the operation
Timepoint
4-8-24 hour
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group Group 2: After removal of the gallbladder, intraperitoneal infiltration of 20 ml of 0.25% bupivacaine solution in the bed of the gallbladder and under the right dome of the diaphragm.
Category
Treatment - Surgery
2
Description
Control group: Intervention group: Group 1: local infiltration (port site) of 20 ml of 0.25% bupivacaine solution at the end of the operation before closing the wound
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Aria hospital mashhad
Full name of responsible person
Dr.Hamed beyzaee
Street address
Mashhad - Jahanbani Street - Eastern Golestan Crossroads
City
mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3222 9098
Email
nfo@aria-hospit.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tooraj zandbaf
Street address
East golestan st 4, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3222 9096
Email
nfo@aria-hospital.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Shabnam shfieejafarabad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 29 . daneshamooz st 6, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188869864
Phone
+98 51 3768 2305
Email
shbnmshafiee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad javad ghamari
Position
Medical doctor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
East golestan5 , mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3222 9096
Email
ghamarimj@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shabnam shafiee jafarabad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 29, daneshamooz st 6, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188869864
Phone
+98 51 3768 2305
Email
shbnmshafiee@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