Liposomal Bupivacaine and Transoral Robotic Surgery

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05862792

Collaborator

(none)

Enrollment

Location

31.5

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Cancer Dysphagia, Oropharyngeal Post Operative Pain Transoral Robotic Surgery	Drug: Liposomal bupivacaine

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 15, 2025

Anticipated Study Completion Date :

Jan 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
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: Tylenol 650 mg every 4 hours as needed for mild pain Oxycodone 5 mg every 4 hours as needed for moderate pain 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.	Drug: Liposomal bupivacaine We will inject liposomal bupivacaine into the surgical bed. Other Names: EXPAREL
TORS + Postoperative Antipyretics and Opioids Group Per standard of care, subjects in this group will only be given a pain regimen including: Tylenol 650 mg every 4 hours as needed for mild pain Oxycodone 5 mg every 4 hours as needed for moderate pain 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.

Arm

Intervention/Treatment

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: Tylenol 650 mg every 4 hours as needed for mild pain Oxycodone 5 mg every 4 hours as needed for moderate pain 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.

Drug: Liposomal bupivacaine

We will inject liposomal bupivacaine into the surgical bed.

Other Names:

EXPAREL

TORS + Postoperative Antipyretics and Opioids Group

Per standard of care, subjects in this group will only be given a pain regimen including: Tylenol 650 mg every 4 hours as needed for mild pain Oxycodone 5 mg every 4 hours as needed for moderate pain 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.

Outcome Measures

Primary Outcome Measures

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
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 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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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