Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

NCT ID: NCT04970680

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-07-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

blind glossopharyngeal nerve block

patients will have the glossopharyngeal nerve block with the blind technique

Group Type: ACTIVE_COMPARATOR

glossopharyngeal nerve block

Intervention Type: PROCEDURE

glossopharyngeal nerve block either blindly or using the ultrasonic technique

ultrasonic glossopharyngeal nerve block

patients will have the glossopharyngeal nerve block using the ultrasonic technique

Group Type: ACTIVE_COMPARATOR

glossopharyngeal nerve block

Intervention Type: PROCEDURE

glossopharyngeal nerve block either blindly or using the ultrasonic technique

Interventions

glossopharyngeal nerve block

glossopharyngeal nerve block either blindly or using the ultrasonic technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

Lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

glossopharyngeal nerve block

Identifier Type: -

Identifier Source: org_study_id