Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cancer of Head and Neck, Narcotic Use

In brief

Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.

Key facts

Study ID

NCT03682367

Run by

University of California, Davis

People needed

8

Starts

2018-12-01

Expected to finish

2020-04-06

Last updated by the study team

2021-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing major head and neck surgery with concomitant free flap reconstruction surgery at UCDMC (oncology and non-oncologic): There will be two groups. Group 1 will include reconstruction with fibula free flap only. Group 2 will include any other free flap reconstruction, including scapular free flap, radial forearm free flap, anterolateral thigh free flap, anteromedial thigh free flap, and latissimus dorsi free flap.
• Patients naïve to gabapentin
• Adult patients >18 years of age and able to consent

You may not qualify if…

• Patients who are already taking scheduled gabapentin
• Patients allergic to gabapentin
• Chronic opioid use not from active head and neck cancer
• Illicit drug use (per report)
• Patients with known renal compromise, such that Creatinine clearance is < 30
• Patient with known hepatic insufficiency or cirrhosis
• Adults unable to consent
• Individuals less than 18 years old
• Pregnant women
• Prisoners

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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