Determination of pain level after abdominal surgery in patients receiving ketorolac and nasocalcin spray or lidocaine and nasocalcin spray in referral patients.
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 58 patients. An online random number table was used for randomization.
Settings and conduct
The drugs were divided by the head of the surgery department as A/B:A(receiver of nasocalcin spray and Ketorolac ampoule intravenously)and B(recipient of nasocalcin spray and lidocaine ampoule intravenously).The doctor and the patient were not aware of which group the patient was in.Medicines were administered to the patients upon entering the operating room and in the recovery room
The place of treatment was Bo Ali Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Entry requirements: 15-75 years old
Informed and written consent
Non-use of drugs and alcohol
Elective surgery
Conditions of non-entry: reduced level of consciousness
Hemodynamic disorder
Abnormal bleeding during
The operation lasts more than 4 hours
Intervention groups
Intervention:D(receiver of nasocalcin spray and ketorolac ampoule intravenously)control:placebo recipient(receiver of nasocalcin spray and lidocaine ampoule intravenously)before abdominal surgery
Main outcome variables
Postoperative pain score based on visual analog scale The amount of drug received during the first 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230710058733N1
Registration date:2023-09-26, 1402/07/04
Registration timing:retrospective
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Mahdiya Qasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
mahdieh.ir72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-20, 1400/06/29
Expected recruitment end date
2023-06-19, 1402/03/29
Actual recruitment start date
2023-06-19, 1402/03/29
Actual recruitment end date
2023-09-10, 1402/06/19
Trial completion date
2023-09-10, 1402/06/19
Scientific title
Comparison of pain after abdominal surgery in patients receiving ketorolac and nasocalcin spray or lidocaine and nasocalcin spray
Public title
Comparison of pain after abdominal surgery in patients receiving ketorolac and nasocalcin spray or lidocaine and nasocalcin spray
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 15-75 years old
Sign a personal consent form to enter the study
American Society of Anesthesiologists 1-2
Non-use of drugs and alcohol
Elective surgery
Exclusion criteria:
Decreased level of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
Length of operation more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
59
Actual sample size reached:
59
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a list of all patients who were willing to participate in the study was first prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 29 as group A and 30 to 59 as group B. So, using the online random number table, the patients were divided into two groups (A group receiving intravenous nasocalcin spray and Ketorolac ampoule and B group receiving intravenous nasocalcin spray and lidocaine ampoule).
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.IAU.TMU.REC.1401.169
Health conditions studied
1
Description of health condition studied
Pain after abdominal surgery
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
Pain
Timepoint
1 hour and 6, 12, 24 hours after the operation, the amount
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The amount of narcotic (pethidine) received after the operation
Timepoint
After surgery
Method of measurement
Amount of drug used.
Intervention groups
1
Description
2 puffs of nasocalcin and Ketorolac 30 mg ampoules were received intravenously. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS>5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse.
Category
Prevention
2
Description
They received 2 puffs of nasocalcin spray and lidocaine ampoules intravenously, and after the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight) , midazolam 0.01 mg per kg of patient weight, fentanyl 2-3 macros per kg of patient weight and atrocurium 0.5 mg per kg of patient weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50/50) ) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then after the surgery and at 6 hours , 12,24, after the operation, the pain level of the patients was checked based on the VAS model, and in the case of VAS>5, pethidine 30-50 mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in a questionnaire by a trained nurse. It was registered.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Dr. Mahnaz Narimani Zamanabadi
Street address
At the beginning of Damāvand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
Email
booali.hospital96@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Naqipour
Street address
Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mahnaznarimani@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Mahnaz Narimani Zamanabadi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
At the beginning of Damāvand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
Mahdieh.ir72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahnaz Narimani Zamanabadi
Position
University professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
At the beginning of Damāvand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
mahdieh.ir72@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mahnaz Narimani Zamanabadi
Position
University professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
At the beginning of Damāvand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1676855733
Phone
+98 21 7719 0836
Email
mahnaznarimani@gmail.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