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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lidocaine

Ketamine

Saline

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Lidocaine

Ketamine and Lidocaine

Placebo

Arm Description

Ketamine infused at 0.25 mg/kg/hour.

Lidocaine infused at 0.5 mg/kg/hour.

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

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

Outcomes

Primary Outcome Measures

Pain Intensity

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

Full Information

NCT ID

NCT01983020

First Posted

November 7, 2013

Last Updated

April 28, 2017

Sponsor

Beth Israel Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01983020

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beth Israel Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Ketamine infused at 0.25 mg/kg/hour.

Arm Title

Lidocaine

Arm Type

Experimental

Arm Description

Lidocaine infused at 0.5 mg/kg/hour.

Arm Title

Ketamine and Lidocaine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Type

Other

Intervention Name(s)

Saline

Primary Outcome Measure Information:

Title

Pain Intensity

Description

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

Time Frame

postoperative day 1 - 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Kaplan, MD

Organizational Affiliation

Beth Israel Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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