Recruiting

Liposomal Bupivacaine & TORS

Sponsor:

Geisinger Clinic

Code:

NCT05862792

Conditions

Oropharyngeal Cancer

Dysphagia, Oropharyngeal

Post Operative Pain

Transoral Robotic Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal bupivacaine

Study Details

Brief summary:

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.

Conditions

Oropharyngeal Cancer

Dysphagia, Oropharyngeal

Post Operative Pain

Transoral Robotic Surgery

Study ID

NCT05862792

Start date

Jun 1, 2023

Status verified date

Sep, 2025

Completion date

Jan 15, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

Per standard of care, at the conclusion of the TORS procedure, liposomal bupivacaine will be injected into the surgical bed- (bupivacaine liposome suspension 1.3% \[13.3 mg/mL\], intramuscular) in this group. Possible injection sites include the base of tongue and/or tonsil. Total dose injected will be 3-4 mL. Subjects will also be given a pain regimen including:

1. Tylenol 650 mg every 4 hours as needed for mild pain
2. Oxycodone 5 mg every 4 hours as needed for moderate pain
3. Morphine 2mg every 3 hours as needed for breakthrough pain

The treatment type (TORS +/- Liposomal Bupivacaine + Postoperative Antipyretics and Opioids) is determined by the subject's surgeon based on his standard practice.

TORS + Postoperative Antipyretics and Opioids Group

Per standard of care, subjects in this group will only be given a pain regimen including:

1. Tylenol 650 mg every 4 hours as needed for mild pain
2. Oxycodone 5 mg every 4 hours as needed for moderate pain
3. Morphine 2mg every 3 hours as needed for breakthrough pain

The treatment type (TORS +/- Liposomal Bupivacaine + Postoperative Antipyretics and Opioids) is determined by the subject's surgeon based on his standard practice.

Interventions

Liposomal bupivacaine

We will inject liposomal bupivacaine into the surgical bed.

Primary outcome measure

  • Postoperative Pain Control [ Time Frame: 3 months ]
  • Postoperative Dysphagia with Endoscopic Swallow Study [ Time Frame: 3 months ]
  • Postoperative Dysphagia with Dysphagia Survey [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Thorsen Haugen, MD

570-214-7866thaugen@geisinger.edu

Locations

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17821

Contacts

Thorsen Haugen, MD

570-214-7866thaugen@geisinger.edu

More Information

Sponsor

Geisinger Clinic

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • oropharyngeal cancer
  • squamous cell carcinoma
  • postoperative pain
  • transoral robotic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Geisinger Clinic on 2025-09-09.