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Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
glossopharyngeal nerve block
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring analgesia, tonsillectomy

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children aged 3-7 years
  • scheduled for tonsillectomy

Exclusion Criteria:

  • younger or elder children
  • associated adenoidectomy
  • history of allergy to local anaesthetics

Sites / Locations

  • Suez Canal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

blind glossopharyngeal nerve block

ultrasonic glossopharyngeal nerve block

Arm Description

patients will have the glossopharyngeal nerve block with the blind technique

patients will have the glossopharyngeal nerve block using the ultrasonic technique

Outcomes

Primary Outcome Measures

change in face, legs, activity, cry, and consolability (FLACC) score
FLACC is a behavioural pain assessment scale used for nonverbal or preverbal patients who cannot self-report their pain level. Pain is assessed through observation of 5 categories including the face, legs, activity, cry, and consolability. The scale ranges from 0 to 10 where 0 records for no pain and 10 records for the worst pain

Secondary Outcome Measures

need for postoperative analgesia
need to analgesics in doses and frequencies both at rest and with swallowing.
difficulty of the technique
prescribed by the operator either easy or difficult
time consumption
from the start of preparation of the procedure, till the end of the block time in minutes
recovery time
from the end of the surgery, till shifting the patient from operation table to recovery bed time in minutes
surgeon satisfaction assessed by visual analogue scale (VAS)
described by the surgeon him self on a scale ranging from very satisfactory to unsatisfactory
anesthetists self-confidence
described as yes or no
parents satisfaction
described by the parents on a scale ranging from very satisfactory to unsatisfactory
staff nurse satisfaction
described by the recovery nurse and daycare unite nurse on a scale ranging from very satisfactory to unsatisfactory

Full Information

First Posted
March 8, 2021
Last Updated
September 25, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT04970680
Brief Title
Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy
Official Title
Comparison Between Two Techniques of Percutaneous Peristyloid Glossopharyngeal Block as an Analgesic Tool After Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adenotonsillectomy surgery in paediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative haemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. This study aimed to compare the glossopharyngeal nerve block using the blind technique with the use of the ultrasound guidance Primary: FLACC score in the two groups 0,2,4,6 h after surgery at rest and with swallowing Secondary: need to analgesics, the difficulty of the technique, time consumption, recovery time, surgeon satisfaction, parents satisfaction, staff nurse satisfaction, anaesthetist self-confidence
Detailed Description
INTRODUCTION Adenotonsillectomy surgery in paediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative haemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. Sensory fibres of the glossopharyngeal nerve supply the tonsillar and peri-tonsillar areas. Thus, a bilateral glossopharyngeal nerve block may alleviate post-tonsillectomy pain and improve postoperative analgesia. This is a Prospective randomized controlled clinical study, to compare two different technique used to block the glossopharyngeal nerve. AIM OF WORK To improve post tonsillectomy pain control in children Anaesthesia, postoperative analgesia Paediatrics 3-7 years Tonsillectomy NOT adenotonsillectomy Postoperative control of pain OBJECTIVES This study aimed to compare the glossopharyngeal nerve block using the blind technique with the use of the ultrasound guidance Primary: FLACC score in the two groups 0,2,4,6 h after surgery at rest and with swallowing Secondary: need to analgesics, the difficulty of the technique, time consumption, recovery time, surgeon satisfaction, parents satisfaction, staff nurse satisfaction, anaesthetist self-confidence METHODOLOGY 54 ASA I children allocated randomly into two groups: Group BL: Blind percutaneous peristyloid injection Group US: ultrasound-guided percutaneous peristyloid glossopharyngeal nerve block 54 children aged 3 to 7 years undergoing adenotonsillectomy without adenoidectomy were randomized to receive either local blind percutaneous peistyloid glossopharyngeal nerve block (n=27) or the use of ultrasound guidance for the same block (n=27). The pain was assessed by the FLACC scale or Face, Legs, Activity, Cry, Consolability scale, need for analgesics, and acceptance of diet during the postoperative period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
analgesia, tonsillectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindly
Masking
ParticipantOutcomes Assessor
Masking Description
the participant will have the block while anaesthetized, the care provider will do the block either blindly or using ultrasonic, the outcome assessor will not know which one have which technique
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blind glossopharyngeal nerve block
Arm Type
Active Comparator
Arm Description
patients will have the glossopharyngeal nerve block with the blind technique
Arm Title
ultrasonic glossopharyngeal nerve block
Arm Type
Active Comparator
Arm Description
patients will have the glossopharyngeal nerve block using the ultrasonic technique
Intervention Type
Procedure
Intervention Name(s)
glossopharyngeal nerve block
Intervention Description
glossopharyngeal nerve block either blindly or using the ultrasonic technique
Primary Outcome Measure Information:
Title
change in face, legs, activity, cry, and consolability (FLACC) score
Description
FLACC is a behavioural pain assessment scale used for nonverbal or preverbal patients who cannot self-report their pain level. Pain is assessed through observation of 5 categories including the face, legs, activity, cry, and consolability. The scale ranges from 0 to 10 where 0 records for no pain and 10 records for the worst pain
Time Frame
Immediately postoperatively considered as 0 hour, then at 2 hours, again at 4 hours, and lastly at 6 hours after surgery all measures will be both at rest and with swallowing
Secondary Outcome Measure Information:
Title
need for postoperative analgesia
Description
need to analgesics in doses and frequencies both at rest and with swallowing.
Time Frame
immediately postoperatively considered as 0 hour, then at 2 hours, again at 4 hours, and lastly at 6 hours after surgery
Title
difficulty of the technique
Description
prescribed by the operator either easy or difficult
Time Frame
immediately after the intervention
Title
time consumption
Description
from the start of preparation of the procedure, till the end of the block time in minutes
Time Frame
immediately after the intervention
Title
recovery time
Description
from the end of the surgery, till shifting the patient from operation table to recovery bed time in minutes
Time Frame
immediately before shifting the patient to recovery room
Title
surgeon satisfaction assessed by visual analogue scale (VAS)
Description
described by the surgeon him self on a scale ranging from very satisfactory to unsatisfactory
Time Frame
immediately after discharging the patient to home
Title
anesthetists self-confidence
Description
described as yes or no
Time Frame
immediately after the intervention
Title
parents satisfaction
Description
described by the parents on a scale ranging from very satisfactory to unsatisfactory
Time Frame
immediately before discharging the patient to home
Title
staff nurse satisfaction
Description
described by the recovery nurse and daycare unite nurse on a scale ranging from very satisfactory to unsatisfactory
Time Frame
immediately before shifting the patient from the recovery room to the day care unite by recovery nurse, and immediately after discharging the patient to home by daycare unite nurse

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children aged 3-7 years scheduled for tonsillectomy Exclusion Criteria: younger or elder children associated adenoidectomy history of allergy to local anaesthetics
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not yet decided

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Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

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