NCT04176419

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

Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Postoperative Pain Control
• Opioid Consumption

Interventions

Type	Name	Description
DRUG	Ketamine	0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
DRUG	Placebo Ketamine	0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
DRUG	Lidocaine	1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
DRUG	Placebo Lidocaine	1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
DRUG	Acetaminophen	1,000 mg orally at time of check-in to the preoperative unit
DRUG	Placebo Acetaminophen	1,000 mg orally at time of check-in to the preoperative unit
DRUG	Gabapentin	600 mg orally at time of check in to the preoperative unit
DRUG	Placebo Gabapentin	600 mg orally at time of check in to the preoperative unit
DRUG	Celecoxib	200 mg orally at time of check in to the preoperative unit
DRUG	Placebo Celecoxib	200 mg orally at time of check in to the preoperative unit

Timeline

• Start date: 2020-01-17
• Primary completion: 2021-06-23
• Completion: 2021-06-23
• First posted: 2019-11-25
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study