Liposomal Bupivacaine and Transoral Robotic Surgery

Recruiting

• Conditions: Dysphagia, Oropharyngeal; Transoral Robotic Surgery; Oropharyngeal Cancer; Post Operative Pain
• Interventions: Drug: Liposomal bupivacaine

• Registration Number: NCT05862792
• Lead Sponsor: Geisinger Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Study Start: 2023-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2025-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group	Liposomal bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Dysphagia with Dysphagia Survey	3 months	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.
Postoperative Dysphagia with Endoscopic Swallow Study	3 months	Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.
Postoperative Pain Control	3 months	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

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain Medication Usage	3 months	We will be measuring the doses of pain medication that patients requiring during their postoperative course.

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States