Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

NCT00840996 | Completed Results

• 1 other identifier: 08-209
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups; \- A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion. B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.

Conditions

Spine Surgery

Keywords

Spine Surgery; Intraocular pressure; Lidocaine; Epidural Anesthetic

Outcome Measures

Primary Outcomes (2)

• Mean Pain Scores

  The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).

  From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).

• Opioid Medication Requirement, mg in IV Morphine Equivalent

  Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents

  through postoperative day 2 (or discharge, if earlier)

Secondary Outcomes (5)

• Number of Participants With Any Major 30-day Post Operative Complications

  30 days after surgery

• Postoperative Nausea and Vomiting (PONV)

  post op day one and two or till hospital discharge

• Duration of Hospitalization

  At discharge

• 12-item Short Form Survey (SF-12) Physical Health Composite Score

  30 days post operative

• 12-item Short Form Survey (SF-12) Physical Health Composite Score

  90 days post operative

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.

Drug: placebo

Lidocaine

ACTIVE COMPARATOR

Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.

Drug: Lidocaine

Interventions

Lidocaine DRUG

perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours

Also known as: Liodocaine

Lidocaine

placebo DRUG

perioperative placebo IV saline infusion of 2 mg/kg/h with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
• Elective spine surgery
• Two levels laminectomies or above with or without fusion or instrumentatioN
• General anesthesia
• Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team

You may not qualify if:

• contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal)
• renal impairment (serum creatinine \>2 mg/dl),
• seizure disorder requiring medication within 2 years
• planned epidural anesthesia or analgesia

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Roberta Johnson
• Organization: Cleveland Clinic

johnsor13@ccf.org

216-444-9950

Study Officials

• Ehab Farag, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ehag Farag, MD

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 23, 2016
• Results First Posted: December 23, 2016

Record last verified: 2016-10

Locations

US (1)