Liposomal Bupivacaine and Transoral Robotic Surgery

Geisinger Health

Status: Enrolling

Conditions: Oropharyngeal Cancer; Transoral Robotic Surgery; Dysphagia, Oropharyngeal; Post Operative Pain

Treatments: Drug: Liposomal bupivacaine

Study type: Observational

Funder types: Other

Identifiers

NCT05862792

2022-0739

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

TORS + Postoperative Antipyretics and Opioids Group

Description:

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.