Trials Sponsors Conditions Drugs Pricing

Conditions

Dysphagia, Oropharyngeal Oropharyngeal Cancer Post Operative Pain Transoral Robotic Surgery

Keywords

oropharyngeal cancersquamous cell carcinomapostoperative paintransoral robotic surgery

Outcome Measures

Primary Outcomes (3)

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
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
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

Study Arms (2)

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.

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.

Interventions

Liposomal bupivacaineDrug

We will inject liposomal bupivacaine into the surgical bed.

Also known as: EXPAREL

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Liposomal bupivacaine
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult patients undergoing TORS

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Geisinger Clinic
Otherlead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17821, United States

MeSH Terms

Conditions

Oropharyngeal NeoplasmsDeglutition DisordersPain, PostoperativeCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

May 17, 2023

Study Start

June 1, 2023

Actual (reported)

Liposomal Bupivacaine and Transoral Robotic Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

TORS + Postoperative Antipyretics and Opioids Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group

TORS + Postoperative Antipyretics and Opioids Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (1)

Data Sharing

Source record

Locations