Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

Comparison Between Two Techniques of Percutaneous Peristyloid Glossopharyngeal Block as an Analgesic Tool After Tonsillectomy

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: glossopharyngeal nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children aged 3-7 years
• scheduled for tonsillectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: blind glossopharyngeal nerve block; patients will have the glossopharyngeal nerve block with the blind technique	Procedure: glossopharyngeal nerve block; glossopharyngeal nerve block either blindly or using the ultrasonic technique
Active Comparator: ultrasonic glossopharyngeal nerve block; patients will have the glossopharyngeal nerve block using the ultrasonic technique	Procedure: glossopharyngeal nerve block; glossopharyngeal nerve block either blindly or using the ultrasonic technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: analgesia; tonsillectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Glossopharyngeal Nerve Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not yet decided

Drug and device information, study documents

• 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