Clinical trial NCT00840996: Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Official title: Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Keywords: Spine Surgery
Intraocular pressure
Lidocaine
Epidural Anesthetic
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970.

IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus.

There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients.

Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Pain Scores
timeFrame: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).
measure: Opioid Medication Requirement, mg in IV Morphine Equivalent
timeFrame: through postoperative day 2 (or discharge, if earlier)
Secondary outcomes:
measure: Number of Participants With Any Major 30-day Post Operative Complications
timeFrame: 30 days after surgery
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: post op day one and two or till hospital discharge
measure: Duration of Hospitalization
timeFrame: At discharge
measure: 12-item Short Form Survey (SF-12) Physical Health Composite Score
timeFrame: 30 days post operative
measure: 12-item Short Form Survey (SF-12) Physical Health Composite Score
timeFrame: 90 days post operative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ehab Farag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: