TonsillectomyNCT06359925
Suprazygomatic Nerve Block in Tonsillectomy Patients
A study testing Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine and Suprazygomatic maxillary nerve block using Bupivacaine in people with Tonsillectomy, run by Assiut University.
Trial summary
The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine and Suprazygomatic maxillary nerve block using Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2024to 20 Feb 2026
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-10 years old
- The American Society of Anesthesiologists (ASA) I and II
- Children scheduled for tonsillectomy with or without adenoidectomy.
Who cannot join
- Patient's guardian refusal to participate in the study.
- Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- Bleeding diathesis
- History of sleep apnea
- Significant organ dysfunction.
Show all 10Show fewer
- cardiac dysrhythmia.
- congenital heart disease .
- Known allergy to the study drugs.
- Skin lesions or wounds at the puncture site of the proposed block
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Dexmedetomidine Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Tonsillectomy Patients.
The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids.
Read the detailed description
Tonsillectomy is one of the most commonly performed operations worldwide, with postoperative pain being the main cause of morbidity . Unlike most other surgeries, tonsillectomies leave an open wound that heals by secondary intention. Thermal and mechanical injuries lead to inflammation, nerve irritation, and spasms of the pharyngeal muscles that can result in severe pain Because, this procedure is performed primarily on an outpatient basis, postoperative complications, including pain, vomiting, fever, and hemorrhage, can significantly lengthen recovery room stays and lead to emergency department visits and unanticipated hospital admission.
Poorly controlled posttonsillectomy pain can result in decreased oral intake, dysphagia, dehydration, and weight loss. Standard management of postoperative pain following tonsillectomy includes acetaminophen, hydrocodone or oxycodone, and nonsteroidal anti-inflammatory drugs .
Despite scheduled administration of analgesics, postoperative pain is often poorly controlled .
Opioid use and preoperative pain at or remote from the surgical site have been demonstrated to be associated with a higher risk of persistent postoperative pain ,and large cohort studies have reported concerning rates of long-term postoperative opioid use after minor surgery in previously opioid-naı¨ve patients .
Efforts to reduce opioid use, particularly after hospital discharge, require further attention; thus opioid consumption beyond the early postoperative period is an increasingly important outcome measure .
As systemic analgesics have proven inefficacious and insufficient to reliably control post-tonsillectomy pain, regional anesthetic techniques are an option, and although they are in their infancy in terms of development and rarely utilized, they may offer advantages over standard approaches. The tonsils are innervated both by branches of the maxillary division of the trigeminal nerve via the lesser (and perhaps greater) palatine nerves and the tonsillar branches of the glossopharyngeal nerve, whereas the adenoids are innervated exclusively by branches of the lesser palatine nerve. Although some studies have indicated significant reduction of postoperative pain with both pre-incisional ropivacaine injected into the tonsillar fossa and postincisional topical ropivacaine in the tonsillar fossa, a Cochrane review of local anesthetics to reduce post-tonsillectomy pain found no evidence of efficacy .
Given the insufficient evidence and risk of inadvertent injection into the carotid artery, the use of local anesthetics at the surgical site is not currently recommended .
Local anesthetic injected into the pterygopalatine fossa has been described for pediatric cleft palate repair with excellent control of postoperative pain compared with systemic analgesics .
The need for postoperative morphine was completely eradicated in one study. The effects of local anesthetic have been noted to have effects on pain for an inexplicably long period (up to 10 days after injection), long after the local anesthetic wears off The tonsillar bed is innervated by the lesser (and perhaps greater) palatine nerve and the glossopharyngeal nerve . Given that both the greater and lesser palatine nerves originate in the pterygopalatine fossa, this space is a logical anatomic target for regional anesthesia to cover the tonsillar fossa .Targeting of the glossopharyngeal nerve for blockade, while possible, would also ablate the gag reflex, which carries an unacceptably high risk of airway compromise in the aftermath of pharyngeal surgery. The suprazygomatic approach to the pterygopalatine fossa is a technically easy procedure to perform with ultrasound guidance, with an average procedure time of 56 seconds . Suprazygomatic approaches to the pterygopalatine fossa have been associated with fewer complications than infrazygomatic approaches, which include orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury .
Using a suprazygomatic approach and ultrasound guidance, Sola et al. experienced zero technical complications after 50 blocks
- Conditions
- Tonsillectomy
- Being tested
- Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine, Suprazygomatic maxillary nerve block using Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprazygomatic maxillary nerve block using dexmedetomidne and BupivacaineProcedure or surgery
After induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled [45 ]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of [4]mL of [0.5% ]Bupivacaine combined with [1]mL of[ 5]µg dexmedetomidine. The injectate is delivered over [15-20 ] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side.
Suprazygomatic maxillary nerve block using BupivacaineProcedure or surgery
After induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled [45 ]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of [4]mL of [0.5% ]Bupivacaine combined with [1]mL normal saline . The injectate is delivered over [15-20 ] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Active comparator | Suprazygomatic maxillary nerve block using Dexmedetomidine Plus Bupivacaine Receives: Procedure: Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine |
| Group c( control) | Placebo comparator | Suprazygomatic maxillary nerve block using Bupivacaine only Receives: Procedure: Suprazygomatic maxillary nerve block using Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score
Postoperative pain will be recorded using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores at admission to the PACU [0] minutes (baseline), [30 ]minutes, [1], [4], [8],[ 12], [18] and [24] hours postoperatively. where the minimum score of zero (no pain) and the maximum score of 12 (the most severe pain). Children with the modified CHEOPS [ ≥ 5 ]will be given supplemental analgesia with IV paracetamol 15 mg/kg , Pain scores will be recorded 15-20 minutes following the administration of this supplemental analgesia to assess pain relief. The number of children that required postoperative rescue analgesics, the first time to rescue analgesia, and the total amount of rescue analgesia consumed within [24] hours postoperatively will be recorded.
Measured: 24 hours
Secondary outcomes (2)
time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale
Emergency agitation (EA) will be evaluated using Paediatric Anaesthesia Emergence Delirium (PAED) scale; upon admission to the PACU (0 min, baseline),( 30), and( 60 ) min until discharge from the PACU.
The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.
Emergence agitation and postoperative pain (scores of ≥ 10) will be managed by intravenous doses of fentanyl( 0.5) mic/kg, repeated after [10 ] min if the child still agitated or in pain, with a maximum total dose of 2 mic/kg. Patients who showed EA were monitored continuously until the EA subsided spontaneously or with medication.
Measured: 24 hours
Parents satisfaction score
Parental satisfaction will be determined 24 h after the surgery by an anesthetist blinded to the study groups. The child's comfort, activity level and the presence or absence of pain will be used to determine the result as 1 (unsatisfied), 2 (satisfied or good), or 3 (very satisfied or excellent)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start22 Oct 2024 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Asaad Hasan Rizk, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359925
- Sponsor's protocol ID
- Suprazygomatic nerve block
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dexmedetomidine Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Tonsillectomy Patients.
- ClinicalTrials.gov ID
- NCT06359925
- Acronym / sponsor ID
- Suprazygomatic nerve block
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 11 Apr 2024 (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.
The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids.
Detailed description
Tonsillectomy is one of the most commonly performed operations worldwide, with postoperative pain being the main cause of morbidity . Unlike most other surgeries, tonsillectomies leave an open wound that heals by secondary intention. Thermal and mechanical injuries lead to inflammation, nerve irritation, and spasms of the pharyngeal muscles that can result in severe pain Because, this procedure is performed primarily on an outpatient basis, postoperative complications, including pain, vomiting, fever, and hemorrhage, can significantly lengthen recovery room stays and lead to emergency department visits and unanticipated hospital admission.
Poorly controlled posttonsillectomy pain can result in decreased oral intake, dysphagia, dehydration, and weight loss. Standard management of postoperative pain following tonsillectomy includes acetaminophen, hydrocodone or oxycodone, and nonsteroidal anti-inflammatory drugs .
Despite scheduled administration of analgesics, postoperative pain is often poorly controlled .
Opioid use and preoperative pain at or remote from the surgical site have been demonstrated to be associated with a higher risk of persistent postoperative pain ,and large cohort studies have reported concerning rates of long-term postoperative opioid use after minor surgery in previously opioid-naı¨ve patients .
Efforts to reduce opioid use, particularly after hospital discharge, require further attention; thus opioid consumption beyond the early postoperative period is an increasingly important outcome measure .
As systemic analgesics have proven inefficacious and insufficient to reliably control post-tonsillectomy pain, regional anesthetic techniques are an option, and although they are in their infancy in terms of development and rarely utilized, they may offer advantages over standard approaches. The tonsils are innervated both by branches of the maxillary division of the trigeminal nerve via the lesser (and perhaps greater) palatine nerves and the tonsillar branches of the glossopharyngeal nerve, whereas the adenoids are innervated exclusively by branches of the lesser palatine nerve. Although some studies have indicated significant reduction of postoperative pain with both pre-incisional ropivacaine injected into the tonsillar fossa and postincisional topical ropivacaine in the tonsillar fossa, a Cochrane review of local anesthetics to reduce post-tonsillectomy pain found no evidence of efficacy .
Given the insufficient evidence and risk of inadvertent injection into the carotid artery, the use of local anesthetics at the surgical site is not currently recommended .
Local anesthetic injected into the pterygopalatine fossa has been described for pediatric cleft palate repair with excellent control of postoperative pain compared with systemic analgesics .
The need for postoperative morphine was completely eradicated in one study. The effects of local anesthetic have been noted to have effects on pain for an inexplicably long period (up to 10 days after injection), long after the local anesthetic wears off The tonsillar bed is innervated by the lesser (and perhaps greater) palatine nerve and the glossopharyngeal nerve . Given that both the greater and lesser palatine nerves originate in the pterygopalatine fossa, this space is a logical anatomic target for regional anesthesia to cover the tonsillar fossa .Targeting of the glossopharyngeal nerve for blockade, while possible, would also ablate the gag reflex, which carries an unacceptably high risk of airway compromise in the aftermath of pharyngeal surgery. The suprazygomatic approach to the pterygopalatine fossa is a technically easy procedure to perform with ultrasound guidance, with an average procedure time of 56 seconds . Suprazygomatic approaches to the pterygopalatine fossa have been associated with fewer complications than infrazygomatic approaches, which include orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury .
Using a suprazygomatic approach and ultrasound guidance, Sola et al. experienced zero technical complications after 50 blocks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Active comparator | Procedure: Suprazygomatic maxillary nerve block using dexmedetomidne and BupivacaineSuprazygomatic maxillary nerve block using Dexmedetomidine Plus Bupivacaine |
| Group c( control) | Placebo comparator | Procedure: Suprazygomatic maxillary nerve block using BupivacaineSuprazygomatic maxillary nerve block using Bupivacaine only |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-10 years old
- The American Society of Anesthesiologists (ASA) I and II
- Children scheduled for tonsillectomy with or without adenoidectomy.
Key exclusion criteria (10 listed)
- Patient's guardian refusal to participate in the study.
- Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
- Bleeding diathesis
- History of sleep apnea
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 |
|---|---|---|
| Suprazygomatic maxillary nerve block using dexmedetomidne and BupivacaineAfter induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled [45 ]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of [4]mL of [0.5% ]Bupivacaine combined with [1]mL of[ 5]µg dexmedetomidine. The injectate is delivered over [15-20 ] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side. | Procedure or surgery | Group S |
| Suprazygomatic maxillary nerve block using BupivacaineAfter induction of general anaesthesia blockade of the contents of the pterygopalatine fossa is performed bilaterally before starting surgery as follows: After complete aseptic skin preparation and under ultrasound guidance images are obtained with a high-frequency linear array probe. The ultrasound transducer is placed in the infrazygomatic area, over the maxilla, angled [45 ]degree cephalad. This probe position allows visualization of the pterygopalatine fossa,The needle is advanced using an out-of-plane approach, and the needle tip can usually be identified during movements. the injectate consisted of [4]mL of [0.5% ]Bupivacaine combined with [1]mL normal saline . The injectate is delivered over [15-20 ] seconds, while observing the spread of the local anesthetic under ultrasoundThe same procedure is then repeated on the contralateral side. | Procedure or surgery | Group c( control) |
Primary outcome
time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score
Time frame: 24 hours
Postoperative pain will be recorded using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scores at admission to the PACU [0] minutes (baseline), [30 ]minutes, [1], [4], [8],[ 12], [18] and [24] hours postoperatively. where the minimum score of zero (no pain) and the maximum score of 12 (the most severe pain). Children with the modified CHEOPS [ ≥ 5 ]will be given supplemental analgesia with IV paracetamol 15 mg/kg , Pain scores will be recorded 15-20 minutes following the administration of this supplemental analgesia to assess pain relief. The number of children that required postoperative rescue analgesics, the first time to rescue analgesia, and the total amount of rescue analgesia consumed within [24] hours postoperatively will be recorded.
2 secondary outcomes
time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale
Time frame: 24 hours
Parents satisfaction score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine and Suprazygomatic maxillary nerve block using Bupivacaine in people with Tonsillectomy, run by Assiut University.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Asaad (01147322947, asaadahmed2521997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score (time frame: 24 hours). 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 11 Apr 2024.