Liposomal Bupivacaine and Transoral Robotic Surgery

Post Operative Pain Clinical Trial

Official title:

Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862792
• Other study ID #: 2022-0739
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: November 2023
• Source: Geisinger Clinic
• Contact: Thorsen Haugen, MD
• Phone: 570-214-7866
• Email: thaugen[@]geisinger.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Liposomal bupivacaine
We will inject liposomal bupivacaine into the surgical bed.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Control	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	3 months
Primary	Postoperative Dysphagia with Endoscopic Swallow Study	Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.	3 months
Primary	Postoperative Dysphagia with Dysphagia Survey	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.	3 months
Secondary	Postoperative Pain Medication Usage	We will be measuring the doses of pain medication that patients requiring during their postoperative course.	3 months