Liposomal Bupivacaine and Transoral Robotic Surgery

Part of paid clinical trials in Danville, Pennsylvania.

Sponsor
Geisinger Clinic
Study ID
NCT05862792
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal bupivacaine — DRUG
    We will inject liposomal bupivacaine into the surgical bed.

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Jan 15, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Postoperative Pain Control [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Geisinger Medical CenterDanvillePennsylvania17821
Thorsen Haugen, MD
[email protected]
570-214-7866

Find similar trials in Danville, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Geisinger Medical Center· Danville, PA

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