Comparative Study of the Effect of Apotel and Ketorolac Injection on Post-operative Pain Management and Decrease in Side Effects in Patients undergoing Laparoscopic Cholecystectomy Surgery
Comparative study of the effect of Apotel and Ketorolac injection on post-operative pain management and decrease in side effects in patients undergoing laparoscopic cholecystectomy surgery
Design
This study is a double blind clinical trial that will be done within 15 months. The statistical population includes cholecystectomy patients that using the systematic random allocation method, they will enter the research.
Settings and conduct
Imam Reza Hospital of Kermanshah - The laparoscopic cholecystectomy will be performed using the standard three-port technique. After the laparoscopic surgery, Patients will be divided into two groups so that the first group receiving Apotel and the second group receiving Ketorolac. (Instantly and 4 hours after surgery). Painkiller injections will begin into Recovery-room and by an anesthesiologist for patients. Patients in both intervention groups will not be informed of their medication. (1st Blinding). The treatment continue in the surgery ward by the specified nurse and under the supervision of a Principal Investigator. Patient follow-up within 24 hours; Evaluation of post-operative pain is performed in Instantly, 6, 12, 18 and 24 hours after surgery by an uninformed intern and by a visual Analogue scale (VAS). (2nd Blinding).
Participants/Inclusion and exclusion criteria
Entry requirements : history of cholecystitis, gallstone and gallbladder polyps. No-entry : lack of multiple trauma, lack of body mass index more than 35 and do not install the drain for the patient.
Intervention groups
The 1st intervention group will receive the Apotel and the 2nd intervention group will receive the Ketorolac. (Intravenous injection).
Main outcome variables
Pain, Dosages of painkiller, Nausea, Vomiting, Fever, Gastritis, Constipation, and Side-effects. (Unwanted side-effects are reported only if they occur).
General information
Reason for update
Acronym
ApoLac
IRCT registration information
IRCT registration number:IRCT20200601047627N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Arash Azadmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6301
Email address
a_azadmehr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of the Effect of Apotel and Ketorolac Injection on Post-operative Pain Management and Decrease in Side Effects in Patients undergoing Laparoscopic Cholecystectomy Surgery
Public title
The effect of painkillers on post-operative pain in gallbladder surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of cholecystitis
Patients with biliary colic
Patients with gallstone
Patients with gallbladder polyp (more than 10 mm)
Exclusion criteria:
Pregnant and lactating women
Patients with impaired renal or dialysis function
Patients with heart disease and who should take warfarin during treatment
Patients with contraindications for opioids use
Patients with hemorrhage especially gastrointestinal Bleeding
Patients with high blood pressure history or History of bloodshed
Patients with abuse drug
Patients with asthma, lung disease and allergies to NSAIDs
Patients with multiple trauma.
Patients with a history of psychiatric disorders or unable to communicate verbally
Patients who need anti-emetic or antihistamines before or after surgery.
Patients who should be treated with medication from one month before the surgery or during the study period.
Patients who should be used the painkiller 7 days before the surgery.
Patients who has a drain after surgery.
Patients with a Body Mass Index of more than 35
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population includes cholecystectomy patients that using the systematic random allocation method, they will be divided into two equal groups (In terms of the number of participants) and will enter the research. The division of patients will be based on a table of random numbers and the number of patients entering the study. After entering the PACU, patients will be divided into two groups so that the first group receiving Apotel and the second group receiving Ketorolac.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the laparoscopic surgery, Patients will be divided into two groups so that the first group receiving Apotel and the second group receiving Ketorolac. (Instantly and 4 hours after surgery). Painkiller injections will begin into Recovery-room and by an anesthesiologist for patients. Patients in both intervention groups will not be informed of their medication. (1st Blinding). The treatment continue in the surgery ward by the specified nurse and under the supervision of a Principal Investigator. Patient follow-up within 24 hours; Evaluation of post-operative pain is performed in Instantly, 6, 12, 18 and 24 hours after surgery by an uninformed intern and by a visual Analogue scale (VAS). (2nd Blinding). Also patients will be given Preliminary information about VAS.
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be monitored for pain intensity and The need for painkiller injections within 24 hours. If patients have a score more than 4 in VAS : (0-10), they will be given Pethidine. The nausea and vomiting of patients will be examined during 12 hours after operation in hour 2, 4, 8 and 12 after operation. The score will be given in quantitative terms from 0 to 2. The score will be as follows : 0 : have not, 1 : tolerable and 2 : Intense-unbearable; Also gastritis and constipation will be reported too. The score will be as follows : 0 : have not, 1 : Can be fixed and 2 : continuous-Intense. Fever will always be checked and an antibiotic will be injected if necessary. In this study, Metoclopramide will be injected in case of nausea and Ondansetron in case of vomiting. Also, in case of gastritis, first Pantoprazole and in case of lack of control and need for a second drug, intravenous Ranitidine will be used; In case of constipation, the patient will be given Pidrolax, and if constipation persists (score 2), a colonoscopy should be performed. Finally, the patient's pain rate, the dosages of the painkiller, nausea, vomiting, fever, gastritis and constipation will be reported in each patient's checklist, and the data will be encrypted and entered into statistical software after collection.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Town.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.KUMS.REC.1399.218
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K80.13
ICD-10 code description
Calculus of gallbladder with acute and chronic cholecystitis with obstruction
Primary outcomes
1
Description
Check the rate of post-operative pain in both intervention group separately.
Timepoint
Instantly after surgery (Recovery - before the intervention begins) + 6, 12, 18 and 24 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Visual analogue scale : (0-10)
2
Description
Check the dosages of the painkiller in both intervention group separately.
Timepoint
24 hours after surgery (Surgery wards - after the intervention).
Method of measurement
Register in the checklist : Millilitre (Quantitative)
3
Description
Check the prevalence rate of nausea in both intervention group separately.
Timepoint
2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Visual analogue scale : (0-2)
4
Description
Check the prevalence rate of vomiting in both intervention group separately.
Timepoint
2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Visual analogue scale : (0-2)
5
Description
Check the rate of fever in both intervention group separately.
Timepoint
2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Register in the checklist : Centigrade (Quantitative)
6
Description
Check the prevalence rate of gastritis in both intervention group separately.
Timepoint
2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Visual analogue scale : (0-2)
7
Description
Check the prevalence rate of constipation in both intervention group separately.
Timepoint
2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins).
Method of measurement
Visual analogue scale : (0-2)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Apotel recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection.
Category
Treatment - Drugs
2
Description
Intervention group: Ketorolac recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Soroush
Street address
Imam Reza Hospital, Kermanshah Town.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
surgery_department@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah Town.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 0541
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadhossein Safari
Position
Clinical Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Surgery Dept., Imam Reza Hospital, Kermanshah Town.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
mohammadhosein.safari@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Arash Azadmehr
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Surgery Dept., Imam Reza Hospital, Kermanshah Town.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
surgery_department@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zhila Seyedi
Position
Head-nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Kermanshah Town.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Email
zhila.seyedi@kums.ac.ir
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
Unlimited
When the data will become available and for how long
Unlimited
To whom data/document is available
Unlimited
Under which criteria data/document could be used
Unlimited
From where data/document is obtainable
Send e-mail to : surgery_department@kums.ac.ir
What processes are involved for a request to access data/document
Receive an e-mail from the applicant - Refer the request to the Principal Investigator (PI) - Get a response from the PI - Send data to the applicant (In case of agreement).