Liposomal Bupivacaine and Transoral Robotic Surgery

NCT05862792 | Recruiting FDA Drug

• 1 other identifier: 2022-0739
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Postoperative Pain Medication Usage

  3 months

Study Arms (2)

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.

Drug: Liposomal bupivacaine

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 DRUG

We will inject liposomal bupivacaine into the surgical bed.

Also known as: EXPAREL

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing TORS

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Deglutition Disorders; Pain, Postoperative; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Central Study Contacts

Thorsen Haugen, MD

CONTACT

570-214-7866; thaugen@geisinger.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 15, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)