Perioperative Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery - Full Text View

Sponsored by:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00706524

Purpose

The primary goal is to assess whether Lidocaine/IVPCA is better in morphine requirements and simultaneously not worse in pain control measured by VAS pain score compared to IVPCA alone.

Condition	Intervention
Pain Nausea Vomiting Wound Infection	Drug: propofol, or Etomidate, fentanyl Drug: lidocaine Drug: placebo

MedlinePlus related topics: Anesthesia Nausea and Vomiting

Drug Information available for: Fentanyl Citrate Fentanyl Rocuronium ORG 9426 Propofol Etomidate Lidocaine Thiopental Thiopental sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

To determine if epidural anesthesia after surgery or lidocaine during surgery decreases inflammation after surgery and decreases the need for pain medication compared to intravenous patient controlled analgesia. [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The occurrence in an individual of one or more of the major postoperative complications (cardio-vascular, gastro-intestinal, pulmonary,neurologic) [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
The incidence of PONV, ileus, wound infection, hospital length of stay [and return to function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life measure (the ability of the patients to resume their normal functional capacity) six months after the procedure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2009
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator GeneraL Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion	Drug: propofol, or Etomidate, fentanyl sodium pentothal, propofol, or Etomidate, fentanyl, rocuronium and oxygen.
2: Active Comparator General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.	Drug: lidocaine Continuous infusion of lidocaine (2mg/kg/h) with maximum of 200 mg/h starting with induction of anesthesia and continued during their PACU stay.
3: Placebo Comparator	Drug: placebo placebo

Detailed Description:

Participants undergoing spine surgery will be randomized into one of three groups;General 1) Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion,2) General Anesthesia plus perioperative intravenous lidocaine infusion and post operative patient controlled analgesia or 3) General Anesthesia plus postoperative epidural analgesia plus placebo IV infusion.

After surgery, data will be collected including pain scores and narcotic and anesthesia requirements. Incidents of complications related to surgery or pain medications will be collected, such as bowel function, nausea and vomiting.

Inflammatory mediators will be evaluated in all groups to determine anti-inflammatory effects

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 to 80 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
Male or female patients undergoing complex spinal surgery using posterior approach only
Spine surgery only on the lumbar and thoracic regions - focused range of spinal column with greater anticipated blood loss as compared to cervical spine surgery (Fujita, 1998 - Complications of spinal fusion in adults greater than 60 years old)
Fusion requiring screws and instrumentation - high volume blood loss anticipated with surgeries requiring fusion versus without fusion (Deyo,1992), and with instrumentation versus without instrumentation
Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team

Exclusion Criteria:

Allergy or hypersensitivity to sufentanil, bupivacaine, morphine, or any component of formulations - serious adverse reaction that requires surgery be discontinued
Current or recent drug abuse (within past 6 months) - alters post-operative complications
Pregnancy - risks to fetus and mother potentially fatal
Immune system disease such as HIV, AIDS - alters measurement of inflammatory markers and possible post-operative complications
Undergoing immunosuppressive treatment - alters measurement of inflammatory markers
Recent history of sepsis - alters measurement of inflammatory markers
Contraindications to lidocaine such as heart block and hepatic insufficiency
Heart failure with ejection fraction less than 30%
Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706524

Contacts

Contact: Nancy Graham, BA,CCRP

216-445-7530

grahamn@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Sub-Investigator: Andrea Kurz, MD
Sub-Investigator: Iain Kalfas, M.D.

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:	Ehab Farag, MD	Cleveland Clinic
Study Chair:	Daniel I Sessler, MD	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( Ehab Farag, MD )
Study ID Numbers:	08-269
Study First Received:	June 25, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00706524
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

spine surgery
postoperative pain
lidocaine
morphine

Study placed in the following topic categories:

Morphine
Fentanyl
Vomiting
Rocuronium
Thiopental
Wounds and Injuries
Lidocaine

Disorders of Environmental Origin
Pain
Etomidate
Nausea
Propofol
Pain, Postoperative
Wound Infection

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Cardiovascular Agents
Infection
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009