NCT07246694

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Dec 2025Apr 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 6, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 17, 2025

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The recovery time

    The time from from inhalational anesthetic discontinuation to the first response to verbal command.

    1 hour

Secondary Outcomes (5)

  • Additional intraoperative analgesia

    4 hours

  • Postoperative pain assessment

    The first 24 hours postoperative.

  • Total rescue analgesia

    The first 24 hours postoperative.

  • Incidence of complications

    4 hours

  • Quality of recovery

    The first 24 hours postoperative.

Study Arms (2)

Group I

ACTIVE COMPARATOR

The patient will receive the ultrasound-guided glossopharyngeal nerve block combined with topical airway anesthesia.

Procedure: Glossopharyngeal nerve block

Group c

ACTIVE COMPARATOR

The patient will receive the standard multimodal analgesia.

Other: Standard multimodal analgesia

Interventions

The patient will receive intravenous fentanyl and non opioids analgesics (acetaminophen and non-steroidal anti-inflammatory drugs) with general anesthesia.

Group c

Glossopharyngeal nerve block using ultrasound guidance after induction of general anesthesia plus topical anesthesia before surgical incision.

Group I

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with chronic opioid use.
  • Advanced hepatic, renal, cardiovascular, and neurologic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatma Mahmoud Ahmed, MD

    Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

    PRINCIPAL INVESTIGATOR
  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 6, 2026

Record last verified: 2025-11

Locations