Postoperative PainNCT04970680
Percutaneous Peristyloid Glossopharyngeal Block After Tonsillectomy
A study testing glossopharyngeal nerve block in people with Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- glossopharyngeal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 3-7 years
- scheduled for tonsillectomy
Who cannot join
- younger or elder children
- associated adenoidectomy
- history of allergy to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- glossopharyngeal nerve block
- Keywords
- analgesia, tonsillectomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glossopharyngeal nerve blockProcedure or surgery
glossopharyngeal nerve block either blindly or using the ultrasonic technique
| Study group | Role | What they receive |
|---|---|---|
| blind glossopharyngeal nerve block | Active comparator | patients will have the glossopharyngeal nerve block with the blind technique Receives: Procedure: glossopharyngeal nerve block |
| ultrasonic glossopharyngeal nerve block | Active comparator | patients will have the glossopharyngeal nerve block using the ultrasonic technique Receives: Procedure: glossopharyngeal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (8)
need for postoperative analgesia
need to analgesics in doses and frequencies both at rest and with swallowing.
Measured: 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
Measured: immediately after the intervention
time consumption
from the start of preparation of the procedure, till the end of the block time in minutes
Measured: 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
Measured: 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
Measured: immediately after discharging the patient to home
anesthetists self-confidence
described as yes or no
Measured: immediately after the intervention
parents satisfaction
described by the parents on a scale ranging from very satisfactory to unsatisfactory
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Feb 2019
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindly
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970680
- Sponsor's protocol ID
- glossopharyngeal nerve block
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Techniques of Percutaneous Peristyloid Glossopharyngeal Block as an Analgesic Tool After Tonsillectomy
- ClinicalTrials.gov ID
- NCT04970680
- Acronym / sponsor ID
- glossopharyngeal nerve block
- Conditions
- Postoperative Pain
- Keywords
- analgesia, tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups, each will have peristyloid glossopharyngeal block, one with the help of ultrasound technology and the other blindly
| Arm | Type | Receives |
|---|---|---|
| blind glossopharyngeal nerve block | Active comparator | Procedure: glossopharyngeal nerve blockpatients will have the glossopharyngeal nerve block with the blind technique |
| ultrasonic glossopharyngeal nerve block | Active comparator | Procedure: glossopharyngeal nerve blockpatients will have the glossopharyngeal nerve block using the ultrasonic technique |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 3-7 years
- scheduled for tonsillectomy
Key exclusion criteria (3 listed)
- younger or elder children
- associated adenoidectomy
- history of allergy to local anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glossopharyngeal nerve blockglossopharyngeal nerve block either blindly or using the ultrasonic technique | Procedure or surgery | blind glossopharyngeal nerve block, ultrasonic glossopharyngeal nerve block |
Primary outcome
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
8 secondary outcomes
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
difficulty of the technique
Time frame: immediately after the intervention
time consumption
Time frame: immediately after the intervention
recovery time
Time frame: immediately before shifting the patient to recovery room
surgeon satisfaction assessed by visual analogue scale (VAS)
Time frame: immediately after discharging the patient to home
anesthetists self-confidence
Time frame: immediately after the intervention
parents satisfaction
Time frame: immediately before discharging the patient to home
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: Undecided. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glossopharyngeal nerve block in people with Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.