Liposomal Bupivacaine and Transoral Robotic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal bupivacaine.
- Who it may be relevant to
- Registry conditions: Oropharyngeal Cancer, Dysphagia, Oropharyngeal, Post Operative Pain, Transoral Robotic Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
Overview
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.
Interventions
- Drug Liposomal bupivacaine
We will inject liposomal bupivacaine into the surgical bed.
Primary outcome measures
- Postoperative Pain Control [Time frame: 3 months]
- Postoperative Dysphagia with Endoscopic Swallow Study [Time frame: 3 months]
- Postoperative Dysphagia with Dysphagia Survey [Time frame: 3 months]
Secondary outcome measures (1)
- Postoperative Pain Medication Usage [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Geisinger Medical Center — Danville
Identifiers
NCT: NCT05862792 · 2022-0739