Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

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This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ketamine

Ketamine infused at 0.25 mg/kg/hour.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Lidocaine

Lidocaine infused at 0.5 mg/kg/hour.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Ketamine and Lidocaine

Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Ketamine

Intervention Type DRUG

Placebo

Placebo (saline) given to compare usual treatment against active agents in post operative pain management.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Interventions

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Lidocaine

Intervention Type DRUG

Ketamine

Intervention Type DRUG

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Male and Female \>/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study