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Completed

NCT Number: NCT01983020

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

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Medical Center

New York, 10003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

ketamine

Drug

Saline

Other

Primary outcomes

  1. Pain Intensity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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