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Comparison of local infiltration and intra-peritoneal instillation of Ropivacaine effect on post-op pain, nausea, vomiting and analgesic requirement in laparoscopic cholecystectomy

Protocol summary

Study aim
comparison of local infiltration and intra-peritoneal instillation of Rupivacaine effect on post-op pain, nausea, vomiting and analgesic requirement in laparoscopic cholecystectomy
Design
double blinded randomized clinical trial,phase 3 with parallel group design, has control group, on 120 patients, by rand excel analysis
Settings and conduct
In this double blinded study, 120 patients which candidate for elective or semi-elective laparascopic cholecystectomy on Madani hospital enrolled and divided to 3 groups randomly. At the end of syrgery and during anaesthesia,first group received 20 cc 0.5%Ropivacaine intra-dermally in port's place, second group as same but intra-peritoneally after cholecystectomy in hepatic bed. And control group received nothing. In recovery room and in 2-4-6-12-24 post-op hours, pulse rate, blood pressure, pain(by visual analogue scale), nausea, vomiting and analgesic requirement were evaluated. The participants and evaluator have no information about group allocation.
Participants/Inclusion and exclusion criteria
inclusion criteria: people aged 18-70 yr-cardiologist permission for surgery-no history of headache or migrane- normal renal and hepatic function exclusion criteria: history of previous surgery in abdomen- concurrent pathology in billiary ducts-conversion to open surgery-severe hemodynamic changes during operation-addiction-cardiac disease
Intervention groups
In this double blinded study, 120 patients which candidate for elective or semi-elective laparascopic cholecystectomy on Madani hospital enrolled and divided to 3 groups randomly. First group received 20 cc 0.5%Ropivacaine intra-dermally in port's place, second group at same dosage but intra-peritoneally after cholecystectomy in hepatic bed. And control group received nothing.
Main outcome variables
pain-nausea-vomiting-analgesic requirement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230523058263N1
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
SOHEYLA FARAJI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 360 8876
Email address
sohayla_f7_2012@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local infiltration and intra-peritoneal instillation of Ropivacaine effect on post-op pain, nausea, vomiting and analgesic requirement in laparoscopic cholecystectomy
Public title
Comparison of local infiltration and intra-peritoneal instillation of Ropivacaine effect on post-op pain, nausea, vomiting and analgesic requirement in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people aged between 18-70 permission for surgery from cardiologist consultant no history of headache or migrane normal renal and hepatic function
Exclusion criteria:
history of previous surgery in abdomen concurrent pathology in billiary ducts conversion to open surgery severe hemodynamic changes during operation addiction people whom have cardiac diseases consist of heart failure, ischemic heart disease arrythmia
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization is used in this study. Lenght of block is 6 for each treatment groups, it means that each block consists of 2 persons from intervention and 2 persons from control group. We have intervention group 1(A), group 2(B) and control group(C). Thus according to n!------------ r!(n!-r!) there will be 20 of 6pcs subgroup like (AA,BB,CC) and its different states. Then by using Excel, randomly, one of these blocks will be choosen and based on A B C in block, eligible persons allocated to treatment or control groups and continued to appropriate study volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study, so that evaluator and participants don't know about group allocation. We inform participants about the procedure and that they receive one of treatments randomly and it is not possible for patients to detect which group they are in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz medical university comitee
Street address
Alborz medical science.Taleqani blvd,karaj
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.ABZUMS.REC.1402.042

Health conditions studied

1

Description of health condition studied
cholecystectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain-nausea-vomiting-analgesic requirement
Timepoint
recovery room-2-4-6-12-24 post-op hours
Method of measurement
by questionnaire and visual analogue scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First group receive 20 cc 0.5% Ropivacaine intra-dermal in port's place. Second group as same but intra-peritoneally and third group (control) which received nothing.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Faraji soheyla
Street address
Jahanshahr, madani Square, madani hospital
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3442 7001
Email
info@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohamadi Hamed
Street address
medical science university-Taleqani blvd-Karaj
City
Tehran
Province
Tehran
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Faraji Soheyla
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bakery highway -kudak squar-nahal alley-No10
City
Tehran
Province
Tehran
Postal code
1474613136
Phone
+98 912 360 8876
Email
sohayla_f7_2012@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Faraji soheyla
Position
RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No10.Nahal alley. Kudak Square. Bakery highway
City
Tehran
Province
Tehran
Postal code
۱۴۷۴۶۱۳۱۳۶
Phone
+98 31 2360 8876
Email
sohayla_f7_2012@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Faraji soheyla
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No10.Nahal alley. Kudak Square. Bakery highway
City
Tehran
Province
Tehran
Postal code
1474613136
Phone
+98 912 360 8876
Email
sohayla_f7_2012@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 further 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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
not indicated
When the data will become available and for how long
not indicated
To whom data/document is available
not indicated
Under which criteria data/document could be used
not indicated
From where data/document is obtainable
not indicated
What processes are involved for a request to access data/document
not indicated
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