Phase 3 N=46 Randomized Double-blind Treatment

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

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT01983020 ↗

Enrolled (actual)

Serious AEs

10.9%

Results posted

May 2017

Primary outcome: Primary: Pain Intensity — 6.29; 5.76; 5.51; 6.40 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lidocaine (Drug); Ketamine (Drug); Saline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Medical Center
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Intensity	6.29; 5.76; 5.51; 6.40	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01983020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.