Actively Recruiting

Age: 18Years +
All Genders
ID05862792

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

Led by Geisinger Clinic · Updated on 2025-09-09

80

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with oropharyngeal squamous cell carcinoma to understand how to better manage pain after transoral robotic surgery (TORS). The focus is on whether the use of a local anesthetic called EXPAREL4 (Liposomal Bupivacaine) injected into the surgical site can improve pain relief and swallowing function compared to standard postoperative care without this injection. EXPAREL4 is an FDA-approved anesthetic that provides long-lasting pain control when used during surgery. Participants will receive TORS, and some will have liposomal bupivacaine injected into the surgical wound at the end of the procedure. The injection is given at the base of the tongue and/or tonsil, with a total dose of 3-4 mL. Both groups receive standard postoperative pain medications including Tylenol, oxycodone, and morphine as needed. The choice to use liposomal bupivacaine is based on the surgeon's usual practice. The study compares two groups: one with the anesthetic injection plus standard pain medicines and one with standard pain medicines alone. During the study, participants’ pain levels and swallowing ability will be monitored for up to three months after surgery. Assessments include endoscopic swallow studies and surveys on swallowing difficulties. Researchers will also track the amount of pain medication used after surgery. The study aims to measure postoperative pain control and dysphagia outcomes, helping to improve care for patients undergoing TORS for oropharyngeal cancer.

CONDITIONS

Brief Title

Liposomal Bupivacaine and Transoral Robotic Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients, 18 years of age or older
  • Patients of all genders
  • Patients undergoing transoral robotic surgery
  • Patients able and willing to give consent
Not Eligible

You will not qualify if you...

  • Patients allergic to Bupivacaine or other amide anesthetics
  • Patients with carnitine deficiency

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and initial recovery period

Participants undergo transoral robotic surgery (TORS). Those assigned to the liposomal bupivacaine group receive an injection of liposomal bupivacaine into the surgical bed during surgery. All participants receive a pain management regimen postoperatively.

1 surgical visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 3 months after surgery

Participants are monitored for post-operative pain control, opioid use, and swallow function to evaluate recovery and treatment effects.

Approximately 3 follow-up visits over 3 months

Trial Site Locations

Total: 1 location

1

Geisinger Medical Center

Danville, Pennsylvania, United States, 17821

Actively Recruiting

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Research Team

T

Thorsen Haugen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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