Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970680
• Other study ID #: glossopharyngeal nerve block
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• children aged 3-7 years

• scheduled for tonsillectomy

Exclusion Criteria:

• younger or elder children

• associated adenoidectomy

• history of allergy to local anaesthetics

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• glossopharyngeal nerve block
glossopharyngeal nerve block either blindly or using the ultrasonic technique

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	difficulty of the technique	prescribed by the operator either easy or difficult	immediately after the intervention
Secondary	time consumption	from the start of preparation of the procedure, till the end of the block time in minutes	immediately after the intervention
Secondary	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
Secondary	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
Secondary	anesthetists self-confidence	described as yes or no	immediately after the intervention
Secondary	parents satisfaction	described by the parents on a scale ranging from very satisfactory to unsatisfactory	immediately before discharging the patient to home
Secondary	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