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COMPLETED
NCT04246697
PHASE4

Multimodal Pain Study in Free Flap Patients

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

This study will be 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2019-11-01

Completion Date

2023-05-01

Last Updated

2026-07-07

Healthy Volunteers

No

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States