Glossopharyngeal nerve block compared to Ropivacaine infiltration as part of a multimodal analgesic regimen for post tonsillectomy pain relief in children A randomized controlled clinical study
Glossopharyngeal nerve block compared to Ropivacaine infiltration as part of a multimodal analgesic regimen for post tonsillectomy pain relief in children A randomized controlled clinical study
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 90 patients who will be undergoing tonsillectomy surgery will be enrolled. Eligible patients will be randomly allocated into two equal R, G and C groups by block randomization.
Settings and conduct
Patients who are candidates for tonsillectomy surgery who visit Dena Hospital in Shiraz during the study will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using the random block method. This study will be conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA grade I or II, patients between 4 and 10 years old, Candidate for tonsillectomy surgery and The distance between the hospital and the patient's place of residence should be a maximum of 30 minutes by car. Exclusion criteria: Allergy to the drugs used in the study Positive history of liver, kidney, and Obstructive sleep apnoea.
Intervention groups
Intervention group G: In all three groups, patients receive the analgesic regimen of ketamine and dexamethasone. The surgeon injects 5 ml of Ropivacaine solution on each side of the glossopharyngeal block.
Intervention group R: The surgeon performs the injection using 5 ml of Ropivacaine solution on each side of the tonsil cavity.
Control group C: patients receive Paracetamol and ketorolac in addition to the pain reliever regimen, and in order to blind the study, at the end of the operation, an equal number of injections are performed, similar to groups G and R, using a placebo (normal saline).
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003213N11
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Arash Farbood
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
farboda@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-01, 1402/12/11
Expected recruitment end date
2024-12-01, 1403/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Glossopharyngeal nerve block compared to Ropivacaine infiltration as part of a multimodal analgesic regimen for post tonsillectomy pain relief in children A randomized controlled clinical study
Public title
Glossopharyngeal nerve block compared to Ropivacaine infiltration in improving tonsillectomy pain in children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 4 and 10 years old
Candidate for tonsillectomy or adenotonsillectomy with diagnosis of tonsillitis
The distance between the hospital and the patient's place of residence should be a maximum of 30 minutes by car
Exclusion criteria:
Allergy to the drugs used in the study
Positive history of liver, kidney, Coagulation disorders and Diseases of the digestive system
Positive history of uncontrolled diseases of the cardiovascular system
Obstructive sleep apnoea
Taking painkillers other than study drugs in 24 hours before surgery
Age
From 4 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into three groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups G,R & C. In each block, equal numbers for three groups will be considered in alternative positions. Then 15 blocks of size 6 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
In group G, the surgeon will inject 5 ml of 0.2% ropivacaine solution in the glossopharyngeal block.
In group R, the surgeon will inject 5 ml of 0.2% ropivacaine solution in the tonsil cavity and its surrounding areas.
In group C, at the end of the operation, in order to blind the study in half of the group (15 people), similar to the intervention group (G), the glossopharyngeal nerve block was performed by the surgeon using a placebo (0.9% normal saline) and in 15 people Another group, similar to group (R), is infiltration in the tonsil cavity with a placebo (0.9% normal saline solution).
In the operating room, all study drugs will be provided by the only person familiar with the study (Nurse anesthetist). The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.SUMS.MED.REC.1402.388
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J03.9
ICD-10 code description
Acute tonsillitis, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Every 15 minutes in the recovery room and at 24, 12, 6, 4, 2 hours after surgery
Method of measurement
CHEOPS scale
Secondary outcomes
1
Description
The quality of the patient's sleep
Timepoint
First time
Method of measurement
In respect to standardized questionnaire
2
Description
Painless swallowing
Timepoint
First time
Method of measurement
Patient history taking
3
Description
The level of satisfaction of the patient's parents
Timepoint
After recovery
Method of measurement
In respect to standardized questionnaire
Intervention groups
1
Description
Intervention group (G) : In all three groups, after the induction of anesthesia, the patients receive intravenous drugs of the studied analgesic regimen, which includes 500 μg/kg of ketamine and 150 μg/kg of dexamethasone. All surgeries will be performed by an otolaryngologist and cold dissection with ligature method. At the end of the surgery, in group (G), the surgeon injects 5 ml of 0.2% ropivacaine solution on each side of the glossopharyngeal nerve block. (Using a size 25 spinal needle at a 45 degree angle, it is inserted into the middle part of the palatopharyngeal fold in the back mucosa tissue of the pharynx, and then with a depth of 0.5 cm in the back wall of the pharynx, after negative aspiration, the injection is performed).
Category
Treatment - Drugs
2
Description
Intervention group (R) : At the end of surgery, in group (R), The surgeon w injects 5 ml of 0.2% Ropivacaine solution in the tonsil cavity and its surrounding areas after negative aspiration.
Category
Treatment - Drugs
3
Description
Control group (C) : After the induction of anesthesia, in addition to receiving intravenous drugs for the studied analgesic regimen, which is common in all groups, the basic analgesic regimen includes Paracetamol at the rate of 15 mg/kg and ketorolac at the rate of 470 μg/kg. receive intravenously and in order to blind the study, In group C, at the end of the operation, 15 people, similar to the intervention group (G), and another 15 people, similar to the intervention group (R), were injected using a placebo (0.9% normal saline).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dena Hospital
Full name of responsible person
Maryam Nemati
Street address
Dena Hospital, Blvd-E-Sattar Khan, Zargari Blvd.
City
Shiraz
Province
Fars
Postal code
7186764951
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
Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?