Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy

Sponsor
Suez Canal University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04970680
Collaborator
(none)
84
1
2
41.9
2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: glossopharyngeal nerve block
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindlytwo groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindly
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Comparison Between Two Techniques of Percutaneous Peristyloid Glossopharyngeal Block as an Analgesic Tool After Tonsillectomy
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

  1. 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]

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

  2. difficulty of the technique [immediately after the intervention]

    prescribed by the operator either easy or difficult

  3. time consumption [immediately after the intervention]

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

  4. recovery time [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) [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 [immediately after the intervention]

    described as yes or no

  7. parents satisfaction [immediately before discharging the patient to home]

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

  8. staff nurse satisfaction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children aged 3-7 years

  • scheduled for tonsillectomy

Exclusion Criteria:
  • younger or elder children

  • associated adenoidectomy

  • history of allergy to local anaesthetics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Suez Canal University Ismailia Egypt

Sponsors and Collaborators

  • Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdelrhman Alshawadfy, Lecturer of anesthesia and intensive care, Suez Canal University
ClinicalTrials.gov Identifier:
NCT04970680
Other Study ID Numbers:
  • glossopharyngeal nerve block
First Posted:
Jul 21, 2021
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Abdelrhman Alshawadfy, Lecturer of anesthesia and intensive care, Suez Canal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022