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

NCT01983020 | Completed Phase 3 Results

• 1 other identifier: IRB 073-10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  postoperative day 1 - 3

Study Arms (4)

Ketamine

EXPERIMENTAL

Ketamine infused at 0.25 mg/kg/hour.

Drug: Ketamine

Lidocaine

EXPERIMENTAL

Lidocaine infused at 0.5 mg/kg/hour.

Drug: Lidocaine

Ketamine and Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine; Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Other: Saline

Interventions

Lidocaine DRUG

Ketamine and Lidocaine; Lidocaine

Ketamine DRUG

Ketamine; Ketamine and Lidocaine

Saline OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Ronald Kaplan, MD
• Organization: Beth Israel Medical Center

rkaplan@chpnet.org

Study Officials

• Ronald Kaplan, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 13, 2013
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)