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

Beth Israel Lahey Health

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Other: Saline; Drug: Lidocaine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01983020

IRB 073-10

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 4 patient groups, including a placebo group

Ketamine

Experimental group

Description:

Ketamine infused at 0.25 mg/kg/hour.

Treatment:

Drug: Ketamine

Lidocaine

Experimental group

Description:

Lidocaine infused at 0.5 mg/kg/hour.

Treatment:

Drug: Lidocaine

Ketamine and Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Saline