Multimodal Pain Study in Free Flap Patients

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

Interventions

DRUG

Tylenol

Used for both arms, scheduled

DRUG

Oxycodone

Used for both arms PRN

DRUG

Morphine

Used for both arms PRN

DRUG

Gabapentin

Used for Arm B

DRUG

toradol

Used for Arm B

DRUG

Bupivacaine

Used for Arm B - anesthesia block

Sponsors & Collaborators

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Lisa Shnayder, MD · KUMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2021-06-01

Completion

2023-05-01

FDA Drug

Yes

Countries

• United States

Study Locations