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New cocktail of pain drugs aims to slash opioid use after major cancer surgery

NCT ID NCT04246697

Symptom relief Sponsor: University of Kansas Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a combination of gabapentin, ketorolac, and a nerve block, along with scheduled Tylenol, can reduce the need for opioid painkillers after head and neck cancer surgery involving free flap reconstruction. Half of the 30 participants will receive the standard approach (scheduled Tylenol plus opioids as needed), while the other half will receive the enhanced combination. Researchers will compare opioid use and pain scores between the two groups to see if the new regimen cuts opioid consumption by at least 30% while maintaining good pain control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gabapentin, Ketorolac, Tylenol, Bupivacaine
What this could lead to
If successful, this approach could reduce reliance on opioids for pain control after major head and neck cancer surgery, potentially lowering side effects and addiction risk.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply broadly. The added drugs also carry their own risks, such as kidney injury or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

30 people

The number who actually took part.

Started

Nov 2019

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 .

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Conditions

The condition(s) this trial relates to.

agnosia head and neck cancer Head and Neck Neoplasms pain agnosia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia Head and neck cancer

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

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