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Multimodal Pain Study in Free Flap Patients

Primary Purpose

Head and Neck Cancer, Analgesia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tylenol
Oxycodone
Morphine
Gabapentin
toradol
Bupivacaine
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care A

Standard of Care B

Arm Description

Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): 0-3: no prn meds, reassurance, listen to music, watch TV. 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. 8-10 Morphine 2 mg IV q2h prn breakthrough pain.

Arm B, will include: Arm A description with addition.. Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins

Outcomes

Primary Outcome Measures

Mean morphine equivalents for Arm A
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Mean morphine equivalents for Arm B
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.

Secondary Outcome Measures

Length of stay
Length of stay in days
Post-operative complications
Monitor chart/EMR for bleeding, acute kidney injury, etc.
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.
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.

Full Information

First Posted
October 31, 2019
Last Updated
August 15, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04246697
Brief Title
Multimodal Pain Study in Free Flap Patients
Official Title
Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care A
Arm Type
Active Comparator
Arm Description
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): 0-3: no prn meds, reassurance, listen to music, watch TV. 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Arm Title
Standard of Care B
Arm Type
Experimental
Arm Description
Arm B, will include: Arm A description with addition.. Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Intervention Type
Drug
Intervention Name(s)
Tylenol
Intervention Description
Used for both arms, scheduled
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Used for both arms PRN
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Used for both arms PRN
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Used for Arm B
Intervention Type
Drug
Intervention Name(s)
toradol
Intervention Description
Used for Arm B
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Used for Arm B - anesthesia block
Primary Outcome Measure Information:
Title
Mean morphine equivalents for Arm A
Description
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Time Frame
During the study period of approximately 1 year
Title
Mean morphine equivalents for Arm B
Description
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Time Frame
During the study period of approximately 1 year
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of stay in days
Time Frame
Analyze the first 7 post-operative days but take note of how long they stayed.
Title
Post-operative complications
Description
Monitor chart/EMR for bleeding, acute kidney injury, etc.
Time Frame
Analyze the first 7 post-operative days
Title
Pain assessment for patients
Description
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.
Time Frame
Nurses will use the DVPRS for each assessment while the patient is hospitalized, typically for seven days. Nursing assessments typically are Q2H-Q4H.
Title
Pain assessment for patients
Description
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.
Time Frame
The ABC pain scale will be given once daily for the patient to fill out for the first seven days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Shnayder, MD
Organizational Affiliation
KUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Multimodal Pain Study in Free Flap Patients

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