Protocol summary
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Study aim
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The main is evaluation the pain-preventive effects of different surgical methods in post op pain of LC .also ، their effect will be evaluated inpatients’ hospital stay duration ،analgesic consumption after surgery and patients’ performance of daily,
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Design
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This study is a four-arm parallel, standard-controlled, and double-blinded randomized clinical trial. blinded outcome assure and patients .
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Settings and conduct
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This is a study in minimally invasive surgery field. it will be done in Namazi and Hafez Shiraz' hospital.patiens allocated into four group ،after receive defined intervention ، we start to gathering data. it' s notable that panties ،data collector ans data assure will be blinded to allocation .
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Participants/Inclusion and exclusion criteria
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Eligible participants will be females، candidates of elective LC. are healthy otherwise, have ASA score I OR II, and Body Mass Index ۱۸.۵-۳۰, patients that have a pain catastrophizing scale >۳۰ or unable to speak Persian or currently taking opioids, and had previous hepatobiliary surgery are not eligible for the study .
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Intervention groups
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Controlled group :taking standard protocols of LC ،without any excess intervention.
group II: low intra abdominal CO2 pressure (12mmhg) but this pressure in the other groups will regulated on 15 mmHg .
group III: will receive ۳۰ mg IV ketorolac during surgery
group IV:receive local intra-peritoneal concoction of bupivacaine ۲۰ mg and dexamethasone ۸ mg on the site of removing gall bladder.
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Main outcome variables
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The effect of different interventions in pain prevention، dose of analgesic that needed after surgery ،duration of hospitalization and daily performance .
General information
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Reason for update
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change in number of participation and randomization method .
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221129056662N1
Registration date:
2022-12-13, 1401/09/22
Registration timing:
prospective
Last update:
2023-02-16, 1401/11/27
Update count:
1
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Registration date
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2022-12-13, 1401/09/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-14, 1401/09/23
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Pain preventive effects of different surgical techniques (low-pressure laparoscopy, intra operative ketorolac, and local bupivacaine administration) in female undergoing laparoscopic cholecystectomy.
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Public title
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Evaluation the pain prevention effect of different surgical techniques in laparoscopic cholecystectomy .
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pt should be female .
Age 18 - 65
BMI 18/5 - 30
ASA score I or II
Score that received from pain catastrophizing questionnaire should be less than 30 .
Patient should be without any underlying disease .
Patient should be interested to participate in the study and complete the informed consent .
Exclusion criteria:
Patient is a smoker .
Patient take opium or opium component recently .
Enable to speak in Persian .
emergency surgery .
Previous history of hepatobiliary surgery .
Age less than 18 or more than 65 .
patients that is male .
Body mass index less than 18/5 or more than 30 .
Patients with underlying disease like HTN ، DM and other .
Patients with chronic diseases like liver failure ، renal failure ، respiratory disease ، heart problem and other .
Addiction to tobacco or alcohol .
Addiction to special drug .
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Age
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From 18 years old to 65 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will randomly be divided into four groups, The randomization will be done by an independent external researcher .Randomization will be done by Excel .
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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After takking informed consent, patients are randomly allocated into four groups .
patients wont be informed about allocation .
data collector and data assessor are unaware of allocation .
Only the surgeon knows allocation .
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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This is a double blinded RCT .
Ethics committees
1
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Ethics committee
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Approval date
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2022-12-04, 1401/09/13
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Ethics committee reference number
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IR.SUMS.MED.REC.1401.496
Health conditions studied
1
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Description of health condition studied
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laparoscopic cholecystectomy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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This study is designed to evaluate the effect of pain prevention effect of different surgical technique in post op pain of laparoscopic cholecystectomy. these effects will be evaluated according to score that patients get from pain questionnaire .
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Timepoint
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patients complete the pain questionnaire in first follow up visit. this is 7 days after discharging from hospital .
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Method of measurement
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pain questionnaire
2
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Description
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patient ' s daily performance
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Timepoint
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patients completed daily performance questionnaire at the first follow up visit . this visit will be 7 days after discharging .
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Method of measurement
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daily performance questionnaire
Secondary outcomes
1
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Description
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dose of analgesic
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Timepoint
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during discharge from hospital .
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Method of measurement
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physician 's order that prescribed during hospitalization .
Intervention groups
1
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Description
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Intervention group: All the participants in this trial will go under laparoscopy with Co۲ pressure of ۱۵ mmHg except this group. This experimental group will experience a ۱۲ mmHg intra-abdominal CO۲ pressure .
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Category
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Treatment - Surgery
2
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Description
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Intervention group: The patients who would be allocated in this group will receive a concoction of bupivacaine ۲۰ mg( local anesthesia ) and dexamethasone ۸ mg. mixture will be rubbed on the site of the removed gall bladder before the termination of the operation.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Participants in this group will receive a single ۳۰ mg IV ketorolac just before the surgery ends.
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Category
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Treatment - Drugs
4
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Description
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Control group: these patients will get standard protocol of laparoscopic surgery . all of participators will under go laparoscopic cholecystectomy with four-port technique .
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data will be published after collection without mentioning personal data.
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When the data will become available and for how long
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After completing the study, the data will be accessible.
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To whom data/document is available
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The data will be accessible for researchers .
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Under which criteria data/document could be used
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Using the results for planning and conduct additional research .
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From where data/document is obtainable
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babak۱۳۸۰@gmail.com
halimehg1378@gmail.com
xalirezasadeghix@gmail.com
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What processes are involved for a request to access data/document
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1month
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Comments
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