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Trial Title:
Liposomal Bupivacaine and Transoral Robotic Surgery
NCT ID:
NCT05862792
Condition:
Oropharyngeal Cancer
Dysphagia, Oropharyngeal
Post Operative Pain
Transoral Robotic Surgery
Conditions: Official terms:
Oropharyngeal Neoplasms
Deglutition Disorders
Pain, Postoperative
Bupivacaine
Conditions: Keywords:
oropharyngeal cancer
squamous cell carcinoma
postoperative pain
transoral robotic surgery
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal bupivacaine
Description:
We will inject liposomal bupivacaine into the surgical bed.
Arm group label:
TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group
Other name:
EXPAREL
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.
Criteria for eligibility:
Study pop:
Adult patients undergoing TORS
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Geisinger Medical Center
Address:
City:
Danville
Zip:
17821
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thorsen Haugen, MD
Phone:
570-214-7866
Email:
thaugen@geisinger.edu
Start date:
June 1, 2023
Completion date:
January 15, 2026
Lead sponsor:
Agency:
Geisinger Clinic
Agency class:
Other
Source:
Geisinger Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862792
