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NCT Number: NCT05862792

Liposomal Bupivacaine and Transoral Robotic Surgery

This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.

Recruiting

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Key information

Conditions

Oropharyngeal Cancer Carcinoma Carcinoma, Squamous Cell Deglutition Disorders Digestive System Diseases Dysphagia, Oropharyngeal Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neurologic Manifestations Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Post Operative Pain Postoperative Complications Signs and Symptoms Stomatognathic Diseases Transoral Robotic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

Location status: Recruiting

Location contact

Thorsen Haugen, MD

CONTACT

[email protected]

570-214-7866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, greater than or equal to 18 years of age; Patients of all genders; Patients undergoing transoral robotic surgery; Patient who are able and willing to give consent

Exclusion criteria

  • Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency

Treatment and study plan

Liposomal bupivacaine

Drug

We will inject liposomal bupivacaine into the surgical bed.

Other names: EXPAREL

Primary outcomes

  1. Postoperative Pain Control

    Time frame: 3 months

    We will be measuring subjects' postoperative maximum visual analog pain scores on each postoperative day.

    Scale: 0-10, 0 represents no pain and 10 represents the worst pain

  2. Postoperative Dysphagia with Endoscopic Swallow Study

    Time frame: 3 months

    Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.

  3. Postoperative Dysphagia with Dysphagia Survey

    Time frame: 3 months

    Patients will undergo an evaluation of their swallow function via the MD Anderson Dysphagia Inventory survey with a speech language pathologist during their first postoperative visit.

Secondary outcomes

  1. Postoperative Pain Medication Usage

    Time frame: 3 months

    We will be measuring the doses of pain medication that patients requiring during their postoperative course.

Study contacts

Contact information is provided by the study sponsor or research team.

Thorsen Haugen, MD

CONTACT

[email protected]

570-214-7866

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 17, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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