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

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.

Conditions

• Postoperative Pain Control
• Opioid Consumption

Interventions

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Jamie Ku, MD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-17

Primary Completion

2021-06-23

Completion

2021-06-23

FDA Drug

Yes

Countries

• United States

Study Locations