Perioperative Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

Condition(s) targeted: Pain; Nausea; Vomiting; Wound Infection

Intervention: propofol, or Etomidate, fentanyl (Drug); lidocaine (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Outcomes Research Consortium

Official(s) and/or principal investigator(s):
Ehab Farag, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Daniel I Sessler, MD, Study Chair, Affiliation: The Cleveland Clinic

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

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.

Official title: Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

The occurrence in an individual of one or more of the major postoperative complications (cardio-vascular, gastro-intestinal, pulmonary,neurologic)

The incidence of PONV, ileus, wound infection, hospital length of stay [and return to function

Quality of life measure (the ability of the patients to resume their normal functional capacity) six months after the procedure.

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

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

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

Starting date: June 2008
Last updated: August 11, 2010