Determination of the effect of premeditation with Oral tappentadol or oxycodone for the control of pain after laparoscopic cholecystectomy
Design
Three arm controlled randomised trial with blinded outcome assessment and a parallel group design of 60 patients, enrolled between August 2019 and March 2020. Randomization will be performed using RASS software and assignment ratio 1: 1: 1.
Settings and conduct
Participants who are referred to the operating room of Imam Reza Hospital of Tabriz University of Medical Sciences for laparoscopic cholecystectomy will be enrolled in the study via convenience sampling method. It would be impossible for research personnel involving with participants or analyzing the study results to adjust randomization or discern what product participants were receiving, ensuring true allocation concealment.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients with cholelithiasis candidate for elective laparoscopic cholecystectomy and physical status 1 or 2 according to the American Society of Anesthesiologists Association's physical status classification. Exclusion criteria include the history of chronic consumption of other opioids or painkillers; history of cardiac, liver, respiratory or kidney disease; surgeries of more than one and a half hours and complicated surgeries.
Intervention groups
1- Tapontadol group: Receiving pre-treatment regimens of topentadol 75 mg oral mucosal anesthetics one hour prior to surgery with naproxin + metoclopramide 10 mg
2- Oxycodone group: Receiving pre-treatment regimens of oxycodone 15 mg oral an hour before surgery with naproxen + metoclopramide 10 mg
3- Control group: Without premedication regimen, naproxin + metoclopramide 10 mg
Main outcome variables
Pain intensity; first request for pain medication; amount of pain medication within 12 hours after surgery; pain duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043923N2
Registration date:2019-07-08, 1398/04/17
Registration timing:prospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
aghamohammadi.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of premedication with Tapentadol and Oxycodone sustain release for post operative pain control in Laparascopic cholecystectomy
Public title
Effect of tapontadol and oxycodone in pain control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cholelithiasis undergoing elective laparoscopic cholecystectomy
Physical status 1 or 2 according to the classification of the American Association of Anesthesiologists
Exclusion criteria:
Sensitivity to tapontadol or oxycodone
History of chronic consumption of other opioids or analgesics
Cardiac, liver, respiratory or renal disease
Surgeries for over one and a half hours
Complicated surgeries
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Blocking Method and RASS Software, allocation concealment will ensured by sequentially numbered opaque sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the main investigator, the person assessing the outcomes, and the person responsible for statistical analysis of the data will be kept blinded to assignment. Medications will be provided to the examiners in closed envelopes, which are labeled by a technician other than the original research members.
Placebo
Not used
Assignment
Parallel
Other design features
All patients will be under the same anesthesia method and will be operated by a surgeon.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Emam Reza Hospital, Golgasht St., West Arghavan Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Approval date
2019-04-22, 1398/02/02
Ethics committee reference number
IR.TBZMED.REC.1398.106
Health conditions studied
1
Description of health condition studied
Patients with calculus of gallbladder candidated for laparoscopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Pain intensity
Timepoint
Measuring the pain intensity at the beginning of the study (after surgery) and every two hours after the operation for up to 12 hours
Method of measurement
Visual analogue scale
2
Description
First request for pain medication
Timepoint
From the beginning of the study (after surgery) up to 12 hours after surgery
Method of measurement
Check patient records
3
Description
Amount of pain medication within 12 hours after surgery
Timepoint
From the beginning of the study (after surgery) up to 12 hours after surgery
Method of measurement
Check patient records
4
Description
Pain duration
Timepoint
From the beginning of the study (after surgery) up to 12 hours after surgery
Method of measurement
Self-declaration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Receiving Pre-treatment regimens of one oral tablet of tapentadol 75 mg (NUCYNTA) branded by Collegium Pharmaceutical, Inc., an hour before surgery, with naproxen plus metoclopramide 10 mg
Category
Treatment - Drugs
2
Description
Intervention group 2: Receiving Pre-treatment regimens of one oral tablet of Oxycodone 15 mg (PHAROXY) branded by Collegium Pharmaceutical, Inc., an hour before surgery, with naproxen plus metoclopramide 10 mg
Category
Treatment - Drugs
3
Description
Control group: No premedication regimen which recieve naproxen plus metoclopramide 10 mg.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3698521475
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 984133361928
Email
daghamohamadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Fax
Email
daghamohamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.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