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NCT Number: NCT04970680

Percutaneous Peristyloid Glossopharyngeal Block 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

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Key information

Conditions

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

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged 3-7 years
  • scheduled for tonsillectomy

Exclusion criteria

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

Treatment and study plan

Glossopharyngeal nerve block

Procedure

glossopharyngeal nerve block either blindly or using the ultrasonic technique

Primary outcomes

  1. change in face, legs, activity, cry, and consolability (FLACC) score

    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

    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 outcomes

  1. need for postoperative analgesia

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

    need to analgesics in doses and frequencies both at rest and with swallowing.

  2. difficulty of the technique

    Time frame: immediately after the intervention

    prescribed by the operator either easy or difficult

  3. time consumption

    Time frame: immediately after the intervention

    from the start of preparation of the procedure, till the end of the block time in minutes

  4. recovery time

    Time frame: immediately before shifting the patient to recovery room

    from the end of the surgery, till shifting the patient from operation table to recovery bed time in minutes

  5. surgeon satisfaction assessed by visual analogue scale (VAS)

    Time frame: immediately after discharging the patient to home

    described by the surgeon him self on a scale ranging from very satisfactory to unsatisfactory

  6. anesthetists self-confidence

    Time frame: immediately after the intervention

    described as yes or no

  7. parents satisfaction

    Time frame: immediately before discharging the patient to home

    described by the parents on a scale ranging from very satisfactory to unsatisfactory

  8. staff nurse satisfaction

    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

    described by the recovery nurse and daycare unite nurse on a scale ranging from very satisfactory to unsatisfactory

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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