Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

Ketamine

Brief Summary

The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Placebo Ketamine
  • Drug: Lidocaine
  • Drug: Placebo Lidocaine
  • Drug: Acetaminophen
  • Drug: Placebo Acetaminophen
  • Drug: Gabapentin
  • Drug: Placebo Gabapentin
  • Drug: Celecoxib
  • Drug: Placebo Celecoxib

Condition or Disease

  • Postoperative Pain Control
  • Opioid Consumption

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 292 ()
Funded by: Other

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Clinical Trial Dates

Start date: Jan 17, 2020
Primary Completion: Nov 30, 2020
Completion Date: Jan 31, 2021
Study First Posted: Nov 25, 2019
Results First Posted: Aug 31, 2020
Last Updated: Jan 22, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Cleveland, Ohio, USA

This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.

Eligibility Criteria

Sex: All
Minimum Age: 18

This clinical trial is recruiting

Are you interested in participating in this trial or others? We'd love to help.

More Details

NCT Number: NCT04176419
Other IDs: CASE6319
Study URL: https://ClinicalTrials.gov/show/NCT04176419
Last updated: Jan 27, 2021