Liposomal Bupivacaine and Transoral Robotic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain; Oropharyngeal Cancer; Dysphagia, Oropharyngeal; Transoral Robotic Surgery
• Intervention / Treatment: Drug: Liposomal bupivacaine

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Thorsen Haugen, MD; Phone Number: 570-214-7866; Email: thaugen@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Recruiting
      • Geisinger Medical Center
      • Contact: Thorsen Haugen, MD; Phone Number: 570-214-7866; Email: thaugen@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing TORS

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Tylenol 650 mg every 4 hours as needed for mild pain; Oxycodone 5 mg every 4 hours as needed for moderate pain; 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.	Drug: Liposomal bupivacaine; We will inject liposomal bupivacaine into the surgical bed.; Other Names: EXPAREL
TORS + Postoperative Antipyretics and Opioids Group; Per standard of care, subjects in this group will only be given a pain regimen including: Tylenol 650 mg every 4 hours as needed for mild pain; Oxycodone 5 mg every 4 hours as needed for moderate pain; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Control	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	3 months
Postoperative Dysphagia with Endoscopic Swallow Study	Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.	3 months
Postoperative Dysphagia with Dysphagia Survey	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Medication Usage	We will be measuring the doses of pain medication that patients requiring during their postoperative course.	3 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: postoperative pain; squamous cell carcinoma; oropharyngeal cancer; transoral robotic surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Carcinoma, Squamous Cell; Deglutition Disorders; Oropharyngeal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2022-0739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No