Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

NCT04970680 | Completed DMC

• 1 other identifier: glossopharyngeal nerve block
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

analgesia; tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (8)

• need for postoperative analgesia

  immediately postoperatively considered as 0 hour, then at 2 hours, again at 4 hours, and lastly at 6 hours after surgery

• difficulty of the technique

  immediately after the intervention

• time consumption

  immediately after the intervention

• recovery time

  immediately before shifting the patient to recovery room

• surgeon satisfaction assessed by visual analogue scale (VAS)

  immediately after discharging the patient to home

Study Arms (2)

blind glossopharyngeal nerve block

ACTIVE COMPARATOR

patients will have the glossopharyngeal nerve block with the blind technique

Procedure: glossopharyngeal nerve block

ultrasonic glossopharyngeal nerve block

ACTIVE COMPARATOR

patients will have the glossopharyngeal nerve block using the ultrasonic technique

Procedure: glossopharyngeal nerve block

Interventions

glossopharyngeal nerve block PROCEDURE

glossopharyngeal nerve block either blindly or using the ultrasonic technique

blind glossopharyngeal nerve block; ultrasonic glossopharyngeal nerve block

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 3-7 years
• scheduled for tonsillectomy

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Model Details: two groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindly

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: July 21, 2021
• Study Start: February 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

EG (1)