Clinical trial · Observational
Liposomal Bupivacaine and Transoral Robotic Surgery
Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia, Oropharyngeal | — | UNRESOLVED | — |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Post Operative Pain | — | UNRESOLVED | — |
| Transoral Robotic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Drug: Liposomal bupivacaine
- label
- 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.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available