PREVENTION OF POSTTONSILLECTOMY PAINNCT05513209
Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
A study testing opioid based multimodal anesthesia and pterygopalatine ganglion block based multimodal anesthesia) in people with PREVENTION OF POSTTONSILLECTOMY PAIN and DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, run by Ain Shams University at 1 site in Egypt.
Trial summary
intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, DECREASE POSTOPERATIVE HOSPITAL STAY
- What is being tested?
- opioid based multimodal anesthesia and pterygopalatine ganglion block based multimodal anesthesia)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Aug 2023
- 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 13 years old.
- Elective tonsillectomy or adenotonsillectomy surgery
Who cannot join
- Allergies to xylocaine.
- Developmental delays.
- Significant cognitive impairment.
- American Society of Anesthesiologists (ASA) Class 3 and 4.
- Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay
Read the detailed description
Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.
- Conditions
- PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, DECREASE POSTOPERATIVE HOSPITAL STAY
- Being tested
- opioid based multimodal anesthesia, pterygopalatine ganglion block based multimodal anesthesia)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid based multimodal anesthesiaProcedure or surgery
elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
pterygopalatine ganglion block based multimodal anesthesia)Procedure or surgery
elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| opioid based multimodal anesthesia | Active comparator | One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia. Receives: Procedure: opioid based multimodal anesthesia |
| opioid free pterygopalatine ganglion block based multimodal anesthesia | Active comparator | One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia. Receives: Procedure: pterygopalatine ganglion block based multimodal anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative VAS score
Measured: EVERY HOUR AFTER SURGERY FOR 24 HOURS
Secondary outcomes (5)
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
Measured: 24 HOURS AFTER SURGERY
INTRAOPERATIVE BLOOD PRESSURE
Measured: EVERY 10 MINUTES up to 1 hour
INTRAOPERATIVE HEART RATE
Measured: EVERY 10 MINUTES up to 1 hour
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Measured: DURING SURGERY
length of PACU stay
Measured: one day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREVENTION OF POSTTONSILLECTOMY PAINStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513209
- Sponsor's protocol ID
- IRB00006379 TON
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2022
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
- ClinicalTrials.gov ID
- NCT05513209
- Acronym / sponsor ID
- IRB00006379 TON
- Conditions
- PREVENTION OF POSTTONSILLECTOMY PAIN, DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, DECREASE POSTOPERATIVE HOSPITAL STAY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 24 Aug 2022 (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.
intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay
Detailed description
Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.
Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.
For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid based multimodal anesthesia | Active comparator | Procedure: opioid based multimodal anesthesiaOne hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia. |
| opioid free pterygopalatine ganglion block based multimodal anesthesia | Active comparator | Procedure: pterygopalatine ganglion block based multimodal anesthesia)One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 4 to 13 years old.
- Elective tonsillectomy or adenotonsillectomy surgery
Key exclusion criteria (5 listed)
- Allergies to xylocaine.
- Developmental delays.
- Significant cognitive impairment.
- American Society of Anesthesiologists (ASA) Class 3 and 4.
- Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.
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 |
|---|---|---|
| opioid based multimodal anesthesiaelective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia. | Procedure or surgery | opioid based multimodal anesthesia |
| pterygopalatine ganglion block based multimodal anesthesia)elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia. | Procedure or surgery | opioid free pterygopalatine ganglion block based multimodal anesthesia |
Primary outcome
postoperative VAS score
Time frame: EVERY HOUR AFTER SURGERY FOR 24 HOURS
5 secondary outcomes
TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
Time frame: 24 HOURS AFTER SURGERY
INTRAOPERATIVE BLOOD PRESSURE
Time frame: EVERY 10 MINUTES up to 1 hour
INTRAOPERATIVE HEART RATE
Time frame: EVERY 10 MINUTES up to 1 hour
TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
Time frame: DURING SURGERY
length of PACU stay
Time frame: one day after operation
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 21 Sep 2023.
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 opioid based multimodal anesthesia and pterygopalatine ganglion block based multimodal anesthesia) in people with PREVENTION OF POSTTONSILLECTOMY PAIN and DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING, run by Ain Shams 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 5 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 21 Sep 2023. 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?
postoperative VAS score (time frame: EVERY HOUR AFTER SURGERY FOR 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 21 Sep 2023.