Liposomal Bupivacaine and Transoral Robotic Surgery

NCT ID: NCT05862792

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-01-15

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Liposomal bupivacaine

Intervention Type: DRUG

We will inject liposomal bupivacaine into the surgical bed.

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.

No interventions assigned to this group

Interventions

Liposomal bupivacaine

We will inject liposomal bupivacaine into the surgical bed.

Intervention Type: DRUG

Other Intervention Names

EXPAREL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thorsen Haugen, MD

Role: CONTACT

thaugen@geisinger.edu

570-214-7866

Facility Contacts

Thorsen Haugen, MD

Role: primary

thaugen@geisinger.edu

570-214-7866

Other Identifiers

2022-0739

Identifier Type: -

Identifier Source: org_study_id