Tonsillectomy Postoperative Adverse EventsPhase 4NCT06694077
Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Adenotonsillectomy Patients
A Phase 4 study testing Bupivacaine with Dexamethasone and Bupivacaine only in people with Tonsillectomy Postoperative Adverse Events and Dexamethasone Administration, run by Assiut University.
Trial summary
This study explores the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain relief in children undergoing adenotonsillectomy. The procedure, often performed to address recurrent infections and airway obstruction, results in significant pain due to inflammation and… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Tonsillectomy Postoperative Adverse Events, Dexamethasone Administration, Bupivacaine
- What is being tested?
- Bupivacaine with Dexamethasone and Bupivacaine only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- Parturient of American Society of Anesthesiologists (ASA) class I or II physical status
- Children scheduled for tonsillectomy with 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, 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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of Dexamethasone Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Adenotonsillectomy Patients
This study explores the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain relief in children undergoing adenotonsillectomy. The procedure, often performed to address recurrent infections and airway obstruction, results in significant pain due to inflammation and nerve irtypicallyritation. Traditional pain management methods, such as systemic analgesics, may be inadequate or lead to side effects in children. By combining dexamethasone, a potent anti-inflammatory, with local anesthetics, this trial aims to determine if enhanced pain control and a reduction in opioid use can be achieved.
The randomized, double-blind clinical trial will involve 80 children aged 3 to 10 years, randomized into two groups: one receiving the nerve block with bupivacaine and dexamethasone, and the other receiving bupivacaine alone. Pain will be assessed postoperatively using the FLACC score, with secondary measures including time to first analgesia, total analgesic use, hemodynamic stability, and any complications.
This study aims to demonstrate that the addition of dexamethasone may provide superior pain management in pediatric adenotonsillectomy, offering a safer, opioid-sparing alternative for postoperative care.
Read the detailed description
This study is about the Analgesic Effect of Suprazygomatic Maxillary Nerve Block with and without Dexamethasone in Pediatric Adenotonsillectomy: A Randomized Double-Blinded Clinical Trial," investigates the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain management in children undergoing adenotonsillectomy. Adenotonsillectomy, a frequent surgical procedure in pediatric patients to address chronic infections and airway obstruction, is commonly associated with significant postoperative pain due to thermal and mechanical injury to tissues. This injury triggers inflammation, muscle spasms, and nerve irritation, which can lead to severe discomfort, decreased oral intake, and potential complications like dehydration.
The tonsils are primarily innervated by the maxillary division of the trigeminal nerve and the glossopharyngeal nerve, while the adenoids are innervated by branches of the trigeminal nerve alone. Despite traditional systemic analgesics being standard in pain management for such cases, they may not always provide adequate relief and can introduce undesirable side effects, particularly in pediatric patients. This limitation has spurred interest in regional anesthesia techniques, such as the suprazygomatic maxillary nerve block, which has been used in various facial and dental procedures but is less common in adenotonsillectomy. Combining dexamethasone, a potent corticosteroid known for its anti-inflammatory properties, with local anesthetics could provide enhanced analgesia and prolong the block's duration, potentially reducing the need for additional opioids post-surgery.
This randomized, double-blind, controlled clinical trial will be conducted at the ENT Operating Theatre at Assiut University Hospitals. The study will involve 80 pediatric patients between 3 and 10 years old, classified as ASA physical status I or II, who are scheduled for adenotonsillectomy. Participants will be randomized into two groups of 40 each: Group A will receive a suprazygomatic maxillary nerve block with 0.5% bupivacaine combined with dexamethasone, and Group B will receive the same nerve block with bupivacaine alone.
For statistical analysis, data will be verified, coded, and processed using IBM-SPSS 24.0 software. Mean and standard ddeviations will be calculated for normally distributed variables, and a two-way repeated measures ANOVA will be used to analyze pain score trends over time. A significance level of p<0.05 will be used for all analyses.
Ultimately, this study aims to establish whether adding dexamethasone to the suprazygomatic maxillary nerve block could enhance pain control, reduce the need for systemic analgesics, and improve overall recovery outcomes for pediatric patients undergoing adenotonsillectomy. Positive findings may position this combination as a safer, more effective pain management strategy, potentially improving the postoperative experience and outcomes in pediatric surgeries
- Being tested
- Bupivacaine with Dexamethasone, Bupivacaine only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with DexamethasoneDrug
bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline.
Bupivacaine onlyDrug
bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with Dexamethasone | Experimental | bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline. Receives: Drug: Bupivacaine with Dexamethasone |
| Bupivacaine only | Experimental | bilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline Receives: Drug: Bupivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total amount of analgesic requirements during first the 24hr after two different blocks.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC)
Measured: 1hour , 2hour, 6hour, 12hour, 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillectomy Postoperative Adverse EventsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub saad kamal kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694077
- Sponsor's protocol ID
- 04-2024-200938
- Status last verified
- Oct 2024
- First submitted
- 14 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dexamethasone Plus Bupivacaine Versus Bupivacaine in Suprazygomatic Maxillary Nerve Block for Management of Postoperative Pain in Adenotonsillectomy Patients
- ClinicalTrials.gov ID
- NCT06694077
- Acronym / sponsor ID
- 04-2024-200938
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Nov 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.
This study explores the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain relief in children undergoing adenotonsillectomy. The procedure, often performed to address recurrent infections and airway obstruction, results in significant pain due to inflammation and nerve irtypicallyritation. Traditional pain management methods, such as systemic analgesics, may be inadequate or lead to side effects in children. By combining dexamethasone, a potent anti-inflammatory, with local anesthetics, this trial aims to determine if enhanced pain control and a reduction in opioid use can be achieved.
The randomized, double-blind clinical trial will involve 80 children aged 3 to 10 years, randomized into two groups: one receiving the nerve block with bupivacaine and dexamethasone, and the other receiving bupivacaine alone. Pain will be assessed postoperatively using the FLACC score, with secondary measures including time to first analgesia, total analgesic use, hemodynamic stability, and any complications.
This study aims to demonstrate that the addition of dexamethasone may provide superior pain management in pediatric adenotonsillectomy, offering a safer, opioid-sparing alternative for postoperative care.
Detailed description
This study is about the Analgesic Effect of Suprazygomatic Maxillary Nerve Block with and without Dexamethasone in Pediatric Adenotonsillectomy: A Randomized Double-Blinded Clinical Trial," investigates the effectiveness of adding dexamethasone to a suprazygomatic maxillary nerve block for postoperative pain management in children undergoing adenotonsillectomy. Adenotonsillectomy, a frequent surgical procedure in pediatric patients to address chronic infections and airway obstruction, is commonly associated with significant postoperative pain due to thermal and mechanical injury to tissues. This injury triggers inflammation, muscle spasms, and nerve irritation, which can lead to severe discomfort, decreased oral intake, and potential complications like dehydration.
The tonsils are primarily innervated by the maxillary division of the trigeminal nerve and the glossopharyngeal nerve, while the adenoids are innervated by branches of the trigeminal nerve alone. Despite traditional systemic analgesics being standard in pain management for such cases, they may not always provide adequate relief and can introduce undesirable side effects, particularly in pediatric patients. This limitation has spurred interest in regional anesthesia techniques, such as the suprazygomatic maxillary nerve block, which has been used in various facial and dental procedures but is less common in adenotonsillectomy. Combining dexamethasone, a potent corticosteroid known for its anti-inflammatory properties, with local anesthetics could provide enhanced analgesia and prolong the block's duration, potentially reducing the need for additional opioids post-surgery.
This randomized, double-blind, controlled clinical trial will be conducted at the ENT Operating Theatre at Assiut University Hospitals. The study will involve 80 pediatric patients between 3 and 10 years old, classified as ASA physical status I or II, who are scheduled for adenotonsillectomy. Participants will be randomized into two groups of 40 each: Group A will receive a suprazygomatic maxillary nerve block with 0.5% bupivacaine combined with dexamethasone, and Group B will receive the same nerve block with bupivacaine alone.
For statistical analysis, data will be verified, coded, and processed using IBM-SPSS 24.0 software. Mean and standard ddeviations will be calculated for normally distributed variables, and a two-way repeated measures ANOVA will be used to analyze pain score trends over time. A significance level of p<0.05 will be used for all analyses.
Ultimately, this study aims to establish whether adding dexamethasone to the suprazygomatic maxillary nerve block could enhance pain control, reduce the need for systemic analgesics, and improve overall recovery outcomes for pediatric patients undergoing adenotonsillectomy. Positive findings may position this combination as a safer, more effective pain management strategy, potentially improving the postoperative experience and outcomes in pediatric surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with Dexamethasone | Experimental | Drug: Bupivacaine with Dexamethasonebilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline. |
| Bupivacaine only | Experimental | Drug: Bupivacaine onlybilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parturient of American Society of Anesthesiologists (ASA) class I or II physical status
- Children scheduled for tonsillectomy with adenoidectomy
Key exclusion criteria (7 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
- Significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
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 |
|---|---|---|
| Bupivacaine with Dexamethasonebilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine was added to 0.1 mg.kg-1 dexamethasone and diluted to 2 mL with 0.9% saline. | Drug | Bupivacaine with Dexamethasone |
| Bupivacaine onlybilateral suprazygomatic maxillary nerve block will be performed with 1 mL of 0.5% bupivacaine alone and diluted to 2 mL with 0.9% saline | Drug | Bupivacaine only |
Primary outcome
the total amount of analgesic requirements during first the 24hr after two different blocks.
Time frame: Postoperative 24 hours
1 secondary outcome
Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC)
Time frame: 1hour , 2hour, 6hour, 12hour, 24hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine with Dexamethasone and Bupivacaine only in people with Tonsillectomy Postoperative Adverse Events and Dexamethasone Administration, 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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad Kamal (+2001202626697, abanoubsaad84.6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total amount of analgesic requirements during first the 24hr after two different blocks. (time frame: Postoperative 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 19 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.