NCT04246697

Multimodal Pain Study in Free Flap Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-06-01
• Completion: 2023-05-01
• First posted: 2020-01-29
• Last updated: 2023-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study