Multimodal Pain Study in Free Flap Patients

Head and Neck Cancer Clinical Trial

Official title:

Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246697
• Other study ID #: 00025711
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be fashioned as a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic.
• Patients with a new H&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.

Exclusion Criteria:

• Prior treatment for head and neck cancer.
• Planned treatment with primary radiation or chemoradiation for their head and neck cancer.
• Pregnant or lactating women.
• Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively.
• Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively.
• Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes.
• Patients with documented history of kidney or liver disease.
• Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests.
• Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .

Related Conditions & MeSH terms

• Analgesia
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Tylenol
Used for both arms, scheduled
• Oxycodone
Used for both arms PRN
• Morphine
Used for both arms PRN
• Gabapentin
Used for Arm B
• toradol
Used for Arm B
• Bupivacaine
Used for Arm B - anesthesia block

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean morphine equivalents for Arm A	Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.	During the study period of approximately 1 year
Primary	Mean morphine equivalents for Arm B	Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.	During the study period of approximately 1 year
Secondary	Length of stay	Length of stay in days	Analyze the first 7 post-operative days but take note of how long they stayed.
Secondary	Post-operative complications	Monitor chart/EMR for bleeding, acute kidney injury, etc.	Analyze the first 7 post-operative days
Secondary	Pain assessment for patients	Pain assessment will occur with nurses providing patient a 0-10 pain scale (i.e. 0 being the lowest and 10 being the greatest amount of pain) named the Defense Veterans Pain Rating Scale for each nursing assessment in order to know which pain medications to administer.	Nurses will use the DVPRS for each assessment while the patient is hospitalized, typically for seven days. Nursing assessments typically are Q2H-Q4H.
Secondary	Pain assessment for patients	There is another pain assessment scale that will be distributed once daily to the patients to assess their pain and how it is affecting their functionality. This pain assessment/survey is named the ABC pain scale, which is a qualitative pain assessment.	The ABC pain scale will be given once daily for the patient to fill out for the first seven days.