The efficacy of Ropivacaine Local Injection on Postoperative Pain in Patients with tonsillectomy surgery
Design
Double-Blinded Randomized Clinical Trial
Settings and conduct
99 patients who were compared in three groups of 33 in Shahid Dastgheib, Dena and Khalili hospitals. Patients in the intervention group All patients aged 5 to 12 years with chronic tonsillitis with obstructive symptoms without response to medical treatment are candidates for adenotonsillectomy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with chronic tonsillitis with obstructive symptoms without responding to medical treatment are candidates for adenotonsillectomy Patients who are candidates for elective tonsillectomy. Age 5 to 12 yearsوPatients who are candidates for elective tonsillectomy; consent to participate in this research project.exclusion criteria: coagulation disorders; history of ropivacaine allergy; People with underlying diseases such as asthma; weight less than 15 kg; children with heart, kidney, or liver disease; non-cooperating parents; non-cooperating patients (cerebral palsy, ...)
Intervention groups
Intervention group 1: In this group, 33 patients will inject 3 mg/kg of 1% ropivacaine made by Molteni (equivalent to 5 ccs) 5 minutes before tonsillectomy and 5 ccs of Distilled water 5 minutes after tonsillectomy. Intervention group 2:In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of 1% ropivacaine solution (manufactured by Multeni) and after tonsillectomy. Group 3 or control group: In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of distilled water after tonsillectomy
Main outcome variables
painless after tonsillectomy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043550N3
Registration date:2022-01-12, 1400/10/22
Registration timing:registered_while_recruiting
Last update:2022-01-12, 1400/10/22
Update count:0
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Ashkan Panah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
panah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-26, 1400/10/05
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Ropivacaine Local Injection on Postoperative Pain in Patients with tonsillectomy surgery
Public title
The efficacy of Ropivacaine Local Injection on Postoperative Pain in Patients with tonsillectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for elective tonsillectomy
All patients with chronic tonsillitis with obstructive symptoms without responding to medical treatment who are candidates for adenotonsillectomy
Age 5 to 12 years
Satisfaction with participating in a research project
Exclusion criteria:
History of Coagulation disorders
History of Rupivacaine allergy
Weight less than 15 kg
Children with heart disease
Children with kidney disease
Children with liver disease
Children with respiratory disease
Children with mental disabilities
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. Samples (99 patients) by random block method with 9 blocks (including 33 participants in intervention group 1 and 33 participants in intervention group 2 and 33 participants in the control group) with The use of a table of random numbers extracted from the relevant software will be specified. The blocks are equal and blocking and the ability to assign a random number for concealment by a non-involved person in the research will be done by recording the numbers on non-transparent envelopes, then based on the obtained blocks and the sequence of drug allocation in the operating room This is a double-blind study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Topical injection of ropivacaine solution or placebo is done by grouping and all cases by a surgeon who is blind to the study to minimize errors in the procedure. Randomization will be performed by a nurse who has no role in data collection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.SUMS.MED.REC.1400.413
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.01
ICD-10 code description
Chronic tonsillitis
Primary outcomes
1
Description
Postoperative pain
Timepoint
From the moment of entering the recovery, 1, 4, 8, 16, 24 hours after entering the recovery room.
Method of measurement
Postoperative pain is measured using the Faces Pain Rating Scale at intervals of 1, 4, 8, 16, 24 hours after entering the recovery room by a trained nurse who is unaware of the injectable drug. After the patient is discharged, the trained nurse teaches one of the patient's first-class members in the recovery room and ward in the first few hours how to measure the pain, and records it with their help, and completes the rest at home and by phone at The relevant file is inserted.
Secondary outcomes
1
Description
The effect of rupivacaine injection before and after tonsillectomy on the need for acetaminophen suppositories.
Timepoint
From the moment of entering the recovery, 1, 4, 8, 16, 24 hours after entering the recovery room.
Method of measurement
Faces pain Rating scale
Intervention groups
1
Description
َIntervention group 1: In this group, 33 patients will inject 3 mg/kg of 1% ropivacaine made by Molteni (equivalent to 5 ccs) 5 minutes before tonsillectomy and 5 ccs of Distilled water 5 minutes after tonsillectomy.
Category
Treatment - Drugs
2
Description
َIntervention group 2:In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of 1% ropivacaine solution (manufactured by Multeni) after tonsillectomy.
Category
Treatment - Drugs
3
Description
Group 3 or control group: In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of distilled water after tonsillectomy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospita
Full name of responsible person
Zahra Aria
Street address
Khalili St,
City
Shiraz
Province
Fars
Postal code
71936 16641
Phone
+98 71 3629 1470
Fax
+98 71 3629 1671
Email
khalili@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Zahra Aria
Street address
Hafez Street
City
شیراز
Province
Fars
Postal code
7145683769
Phone
+98 71 3228 8064
Fax
+98 71 3229 8092
Email
dastgheib@sums.ac.ir
3
Recruitment center
Name of recruitment center
Dena Hospital
Full name of responsible person
Zahra Aria
Street address
Bolvar-e-Sattar Khan, No. Sattar Khan cross toward north
City
Shiraz
Province
Fars
Postal code
64951-71867
Phone
+98 71 3649 0411
Email
info@denahospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpoor
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
+98 71 3647 4270
Phone
+98 71 3484 4119
Email
Vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
peyman
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3630 4312
Email
peymanhassanpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan panah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Khalili st
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶۷۱۳۴۸
Phone
+98 71 3629 1470
Email
panah@sums.ac.ir
Web page address
https://khalili.sums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Tabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@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
No - There is not 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