Multimodal Pain Study in Free Flap Patients

University of Kansas

Status and phase

Completed

Phase 4

Conditions

Analgesia

Head and Neck Cancer

Treatments

Drug: toradol

Drug: Morphine

Drug: Oxycodone

Drug: Bupivacaine

Drug: Gabapentin

Drug: Tylenol

Study type

Interventional

Funder types

Other

Identifiers

NCT04246697

00025711

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Standard of Care A

Active Comparator group

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.

Treatment:

Drug: Tylenol

Drug: Oxycodone

Drug: Morphine

Standard of Care B

Experimental group

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

Treatment:

Drug: Tylenol

Drug: Oxycodone

Drug: toradol

Drug: Bupivacaine

Drug: Gabapentin

Drug: Morphine