Cleveland, Ohio 44195


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.


Study summary:

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.


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.


NCT ID:

NCT00706524


Primary Contact:

Principal Investigator
Ehab Farag, MD
The Cleveland Clinic

Gretchen Upton, BA,CCRP
Phone: 216-444-3289
Email: uptong@ccf.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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