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

Phase 3

Completed

Conditions: Postoperative Pain

Interventions: Other: Saline
Drug: Lidocaine
Drug: Ketamine

Registration Number: NCT01983020

Lead Sponsor: Beth Israel Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Exclusion Criteria

Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
Ketamine and Lidocaine	Lidocaine	Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
Lidocaine	Lidocaine	Lidocaine infused at 0.5 mg/kg/hour.
Ketamine	Ketamine	Ketamine infused at 0.25 mg/kg/hour.
Ketamine and Lidocaine	Ketamine	Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour

Primary Outcome Measures

Name	Time	Method
Pain Intensity	postoperative day 1 - 3	The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).

Secondary Outcome Measures