Clinical trial

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

Name

CASE6319

Description

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.

Trial arms

Trial start

2020-01-17

Estimated PCD

2024-04-30

Trial end

2024-10-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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.

Arms:

Treatment Group

Other names:

Ketamine Hydrochloride, Ketamine Hydrochloride Injection, USP

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.

Arms:

Control Group

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

Arms:

Treatment Group

Other names:

Lidocaine Hydrochloride and 5% dextrose, lidocaine hydrochloride injection

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

Arms:

Control Group

Acetaminophen

1,000 mg orally at time of check-in to the preoperative unit

Arms:

Treatment Group

Other names:

Paracetamol, Tylenol, N-acetyl-para-aminophenol, APAP

Placebo Acetaminophen

1,000 mg orally at time of check-in to the preoperative unit

Arms:

Control Group

Gabapentin

600 mg orally at time of check in to the preoperative unit

Arms:

Treatment Group

Other names:

Neurontin

Placebo Gabapentin

600 mg orally at time of check in to the preoperative unit

Arms:

Control Group

Celecoxib

200 mg orally at time of check in to the preoperative unit

Arms:

Treatment Group

Other names:

Celebrex

Placebo Celecoxib

200 mg orally at time of check in to the preoperative unit

Arms:

Control Group

Size

Primary endpoint

Total opioid consumption measured in daily morphine equivalent

at 48 hours postop

Pain levels on Visual Analog Scale (VAS)

Pre-Op, 24 hours postop, and 48 hours postop

Eligibility criteria

Inclusion Criteria: * Undergoing head \& neck free flap reconstruction at the Cleveland Clinic Main Campus * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study * Subjects receiving any other investigational agents * Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days * Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days * Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months * Pregnancy * Contraindication to lidocaine (heart block, heart failure with EF \< 30%) as determined by history of Congestive Heart Failure, or as determined by preoperative evaluation for surgical clearance * In the opinion of the investigator, subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-10-06

1 organization

6 products

2 drugs

2 indications

Organization

Case Comprehensive Cancer Center

Drug

Ketamine

Indication

Postoperative Pain Control