- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246694
Enhanced Recovery After Uvulopalatoplasty
April 30, 2026 updated by: Zagazig University
Combined Glossopharyngeal Nerve Block With Topical Anesthesia for Enhanced Recovery in Obstructive Sleep Apnea Patients Undergoing Uvulopalatoplasty
Obstructive sleep apnea is a prevalent condition often treated surgically with palatoplasty, which improves airway patency and reduces apneic events.
However, postoperative pain and airway discomfort following palatoplasty can be significant, leading to delayed oral intake, increased opioid consumption, and prolonged recovery.
Combining an ultrasound-guided glossopharyngeal nerve block with topical airway anesthesia may provide synergistic analgesia and support a safer recovery profile.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea is a prevalent condition often treated surgically with palatoplasty, which improves airway patency and reduces apneic events.
However, postoperative pain and airway discomfort following palatoplasty can be significant, leading to delayed oral intake, increased opioid consumption, and prolonged recovery.
Enhanced Recovery After Surgery protocols aim to accelerate functional recovery and reduce perioperative morbidity.
Combining an ultrasound-guided glossopharyngeal nerve block with topical airway anesthesia may provide effective analgesia and support a smoother recovery profile.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Al-Sharkia
-
Zagazig, Al-Sharkia, Egypt, 44519
- Zagazig university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed diagnosis of moderate to severe obstructive sleep apnea.
- Patients scheduled for elective palatoplasty under general anesthesia.
- American Society of Anesthesiologists Physical Status class I and II.
Exclusion Criteria:
- Patients with chronic opioid use.
- Advanced hepatic, renal, cardiovascular, and neurologic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I
The patient will receive the ultrasound-guided glossopharyngeal nerve block combined with topical airway anesthesia.
|
Glossopharyngeal nerve block using ultrasound guidance after induction of general anesthesia plus topical anesthesia before surgical incision.
|
|
Active Comparator: Group c
The patient will receive the standard multimodal analgesia.
|
The patient will receive intravenous fentanyl and non opioids analgesics (acetaminophen and non-steroidal anti-inflammatory drugs) with general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The recovery time
Time Frame: 1 hour
|
The time from from inhalational anesthetic discontinuation to the first response to verbal command.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Additional intraoperative analgesia
Time Frame: 4 hours
|
Additional doses of intraoperative fentanyl.
|
4 hours
|
|
Total rescue analgesia
Time Frame: The first 24 hours postoperative.
|
Total rescue analgesic dose needed during the first postoperative 24 hours.
|
The first 24 hours postoperative.
|
|
Incidence of complications
Time Frame: 4 hours
|
Incidence of any complications related to nerve block or local anesthesia such as hematoma formation or local anesthetic systemic toxicity.
|
4 hours
|
|
Postoperative pain assessment
Time Frame: The first 24 hours postoperative.
|
Postoperative pain assessment by the 10 points Visual Analogue Scale at at rest and during swallowing with 0 indicates no pain and 10 indicates the worst pain.
|
The first 24 hours postoperative.
|
|
Quality of recovery
Time Frame: The first 24 hours postoperative.
|
Quality of recovery assessed by the Quality of recovery score-15 at the end of the first 24 hours postoperative.
The Quality of recovery score ranges from 0 to150, with higher scores indicate better recovery.
|
The first 24 hours postoperative.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma Mahmoud Ahmed, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
- Study Director: Alshaimaa Abdelfattah Kamel, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
- Study Director: Osama Yehia Khalifa, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
November 17, 2025
First Posted (Actual)
November 24, 2025
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uvulopalatoplasty Analgesia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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