Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Geisinger Medical Center
RECRUITING
Danville
Contact Information
Primary
Thorsen Haugen, MD
thaugen@geisinger.edu
570-214-7866
Time Frame
Start Date:2023-06-01
Estimated Completion Date:2026-01-15
Participants
Target number of participants:80
Treatments
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.
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.