Multimodal Pain Study in Free Flap Patients

NCT ID: NCT04246697

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-05-01

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.

Conditions

Head and Neck Cancer; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard of Care A

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.

Group Type: ACTIVE_COMPARATOR

Tylenol

Intervention Type: DRUG

Used for both arms, scheduled

Oxycodone

Intervention Type: DRUG

Used for both arms PRN

Morphine

Intervention Type: DRUG

Used for both arms PRN

Standard of Care B

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

Group Type: EXPERIMENTAL

Tylenol

Intervention Type: DRUG

Used for both arms, scheduled

Oxycodone

Intervention Type: DRUG

Used for both arms PRN

Morphine

Intervention Type: DRUG

Used for both arms PRN

Gabapentin

Intervention Type: DRUG

Used for Arm B

toradol

Intervention Type: DRUG

Used for Arm B

Bupivacaine

Intervention Type: DRUG

Used for Arm B - anesthesia block

Interventions

Tylenol

Used for both arms, scheduled

Intervention Type: DRUG

Oxycodone

Used for both arms PRN

Intervention Type: DRUG

Morphine

Used for both arms PRN

Intervention Type: DRUG

Gabapentin

Used for Arm B

Intervention Type: DRUG

toradol

Used for Arm B

Intervention Type: DRUG

Bupivacaine

Used for Arm B - anesthesia block

Intervention Type: DRUG

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Shnayder, MD

Role: PRINCIPAL_INVESTIGATOR

KUMC

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

00025711

Identifier Type: -

Identifier Source: org_study_id