Health TrialsbyHealthPanel

Liposomal Bupivacaine and Transoral Robotic Surgery

ConditionsOropharyngeal CancerDysphagia, OropharyngealPost Operative PainTransoral Robotic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeisinger Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency

Trial population

Adult patients undergoing TORS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Liposomal bupivacaine

    Drug

    We will inject liposomal bupivacaine into the surgical bed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group1 intervention
Group B: TORS + Postoperative Antipyretics and Opioids Group0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

Postoperative Dysphagia with Endoscopic Swallow Study

Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.

Time frame
3 months
3

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.

Time frame
3 months

Secondary outcomes

1

Postoperative Pain Medication Usage

We will be measuring the doses of pain medication that patients requiring during their postoperative course.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Geisinger Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now