Oropharyngeal CancerNCT05862792
Liposomal Bupivacaine and Transoral Robotic Surgery
An observational study of Oropharyngeal Cancer and Dysphagia, Oropharyngeal, run by Geisinger Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, Dysphagia, Oropharyngeal, Post Operative Pain
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 2 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing TORS
Who may be able to join
- 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
Who cannot join
- Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17821
About this study
Official title: Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
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.
- Conditions
- Oropharyngeal Cancer, Dysphagia, Oropharyngeal, Post Operative Pain, Transoral Robotic Surgery
- Being tested
- Liposomal bupivacaine
- Keywords
- oropharyngeal cancer, squamous cell carcinoma, postoperative pain, transoral robotic surgery
- Medical subject headings
- Oropharyngeal Neoplasms, Deglutition Disorders, Pain, Postoperative, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called EXPAREL
We will inject liposomal bupivacaine into the surgical bed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Liposomal bupivacaine | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Postoperative Dysphagia with Endoscopic Swallow Study
Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.
Measured: 3 months
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2023
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862792
- Sponsor's protocol ID
- 2022-0739
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
- ClinicalTrials.gov ID
- NCT05862792
- Acronym / sponsor ID
- 2022-0739
- Conditions
- Oropharyngeal Cancer, Dysphagia, Oropharyngeal, Post Operative Pain, Transoral Robotic Surgery
- Keywords
- oropharyngeal cancer, squamous cell carcinoma, postoperative pain, transoral robotic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group | – | Drug: Liposomal bupivacainePer 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing TORS
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: EXPARELWe will inject liposomal bupivacaine into the surgical bed. | Drug | TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group |
Primary outcome
Postoperative Pain Control
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Postoperative Pain Medication Usage
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Cancer and Dysphagia, Oropharyngeal, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Control (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.