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Liposomal Bupivacaine and Transoral Robotic Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05862792
Enrollment
80
Registered
2023-05-17
Start date
2023-06-01
Completion date
2026-01-15
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Oropharyngeal, Oropharyngeal Cancer, Post Operative Pain, Transoral Robotic Surgery

Keywords

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

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.

Interventions

DRUGLiposomal bupivacaine

We will inject liposomal bupivacaine into the surgical bed.

Sponsors

Geisinger Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Control3 monthsWe 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
Postoperative Dysphagia with Endoscopic Swallow Study3 monthsPatients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.
Postoperative Dysphagia with Dysphagia Survey3 monthsPatients 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

MeasureTime frameDescription
Postoperative Pain Medication Usage3 monthsWe will be measuring the doses of pain medication that patients requiring during their postoperative course.

Countries

United States

Contacts

Primary ContactThorsen Haugen, MD
thaugen@geisinger.edu570-214-7866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026