The effect of intraperitoneal spillage of rupivacaine and ketamine in combination with lung recruitment to reduce pain after laparoscopic gynecological procedures
Determining the effect of intraperitoneal injection of ropivacaine and ketamine to reduce pain after laparoscopic surgeries in women.
Design
prospective and randomized double-blind clinical trial. To determine the sample size with determination software the number of 50 studied samples was obtained, and the patients were selected by easy sampling method. Consecutively, based on the order of reference and using Rand List online randomization software, they will be randomly divided into two equal groups of 25 people and will be included in the study.
Settings and conduct
Patients will be blinded to the type of injected drug.the medicine will be drawn in a syringe by the scrub nurse who is not aware of the study and will be sprayed by the surgeon. This amount will not be suctioned and will remain inside the stomach. Data collection will be done by an anesthetist who is unaware of the type of injected drug
Participants/Inclusion and exclusion criteria
Female with physical condition II or I ASA class candidate for laparoscopic surgery in the age range of 18-60 years in Al-Zahra Hospital, Tabriz. Patient consent to enter the study
Intervention groups
Candidates for laparoscopic surgery at Al-Zahra Hospital will be randomly divided into two groups. After surgery, in the study group, ropivacaine 0.2% and ketamine 0.5 milligrams per kilogram in a total volume of 50 cc will be poured by the surgeon into the intraperitoneal space and the surgical site, and in the control group, 50 cc of normal saline will be used.
Main outcome variables
Reducing the severity of abdominal and shoulder pain after surgery in two study groups; Comparison of hemodynamic changes during and after surgery in two study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221117056529N1
Registration date:2023-03-10, 1401/12/19
Registration timing:registered_while_recruiting
Last update:2023-03-10, 1401/12/19
Update count:0
Registration date
2023-03-10, 1401/12/19
Registrant information
Name
Samin Ehsaninezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3725 5435
Email address
saminehsani100@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraperitoneal spillage of rupivacaine and ketamine in combination with lung recruitment to reduce pain after laparoscopic gynecological procedures
Public title
reduce pain after laparoscopic gynecological procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
II or I ASA class , candidates for laparoscopic surgery for women in the age range of 18-60 years in Al-Zahra Hospital, Tabriz
Patient consent to enter the study
Exclusion criteria:
The existence of any contraindications to the use of ropivacaine and other local anesthetics
The presence of any contraindications for ketamine use: history of seizures, psychological disorders, hypertension, high intracerebral pressure, etc.
Hypersensitivity to ropivacaine or other local anesthetics and ketamine
Concomitant systemic diseases such as any history of cardiovascular, pulmonary, liver, kidney, etc.
Presence of chronic pain in the patient
Addiction to the use of painkillers and drugs
Patient dissatisfaction
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table, they will be randomly divided into two groups of 25 people
in the study and 25 people in the control group. In such a way that in the event of odd, they
would be in rupivacaine and ketamine and in the event of even, they would be in Sodium Chloride 0.9%
group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The administration of anesthesia and fluids (volume and type of serum) during anesthesia
is performed by an anesthesiologist and anesthesia technician, and all data will be collected
and recorded in the checklist by an anesthesiologist who is unaware of the division of the
groups. patient are also unaware of the division of the
groups.
The effects of the combination of ropivacaine and ketamine, pain reduction, laparoscopic surgeries for women
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
The percentage of people in whom abdominal and shoulder pain has decreased after laparoscopic surgeries
Timepoint
Upon entering the operating room, standard monitoring including NIBP, HR, RR, ECG, SPO2, and ETCo2 is done and will continue. The severity of shoulder and abdominal pain is recorded every 15 minutes until the patient's complete recovery and delivery to the ward.
Method of measurement
The severity of shoulder and abdominal pain, based on VAS score and degree of sedation according to Ramsay sedation score, is recorded every 15 minutes until the patient's complete recovery and delivery to the ward.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 women who have undergone laparoscopic surgery will be injected with ropivacaine 0.2% and ketamine 0.5 mg/kg in a total volume of 50 cc by the surgeon into the intraperitoneal space and the surgical site. In the control group, 50 cc of 0.09% normal saline serum will be used. Before the removal of trocars in both groups, lung recruitment maneuver will be performed. In the PACU, the patient will be monitored and treated if there is a specific complication. The severity of shoulder and abdominal pain, the degree of sedation will be recorded every 15 minutes until delivery to the ward, and in case of VAS scores higher than 3, treatment will be given, and the dose of supplementary drugs will also be recorded.
Category
Treatment - Drugs
2
Description
Control group: After surgery, 50 cc of normal saline will be used in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AL zahra hospital
Full name of responsible person
Samin Ehsaninezhad
Street address
AL zahra hospital,Bagh shomal square,Artesh street
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9160
Email
saminehsani100@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Next to the Emamreza hospital ,Golgasht,Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۶۴۷۱
Phone
+98 41 3337 6923
Email
reyhane.abri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reyhane Abri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AL zahra hospital,Bagh shomal square,Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9160
Email
reyhane.abri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhane Abri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AL zahra hospital,Bagh shomal square,Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9160
Email
reyhane.abri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhane Abri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
AL zahra hospital,Bagh shomal square,Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9160
Email
reyhane.abri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A part of the data, such as information related to the main outcome or the like, can be shared.
When the data will become available and for how long
Access starts from 1401
To whom data/document is available
It will be available for researchers working in academic and scientific institutions and even people working in industry.
Under which criteria data/document could be used
Data must be protected
From where data/document is obtainable
Samin Ehsaninezhad 09364702225fu
What processes are involved for a request to access data/document