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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840996
• Other study ID #: 08-209
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: August 24, 2012
• Start date: May 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: Outcomes Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00706524

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

• Spine surgery

• Two levels laminectomies or above with or without fusion or 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, or any component of formulations

• Current or recent drug abuse (within past 6 months)

• Pregnancy

• Immune system disease such as HIV, AIDS

• Undergoing immunosuppressive treatment

• Recent history of sepsis

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Drug:
• Lidocaine
General Anesthesia plus perioperative intravenous lidocaine infusion and post operative patient controlled analgesia
• placebo
General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores	The pain score as measured by VAS every 30 minutes during PACU stay, then per nursing floor protocol (roughly every 4-6 hours), and pain medications requirement for entire hospital stay in the two groups.	day one	No
Primary	pain medication requirement	The pain score as measured by VAS every 30 minutes during PACU stay, then per nursing floor protocol (roughly every 4-6 hours), and pain medications requirement for entire hospital stay in the two groups.	daily, for duration of hospital stay	No
Secondary	major post operative complications	The occurrence in an individual of one or more major complications.	daily, throughout hospitalization	No
Secondary	Inflammatory markers	Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after the operation at time (T1), and on postoperative day one and two (T2 and T3).	day one and two	No
Secondary	Postoperative Nausea and Vomiting (PONV)	Postoperative Nausea and Vomiting (PONV)will be noted during day one post operative.	day one	No
Secondary	Postoperative Bowel Function	Patients will be questioned at each visit and asked to note the time of first flatus and first bowel movement. Oral intake will be measured until subjects tolerated regular meals.	daily through hospitalization	No
Secondary	Duration of hospitalization	Length of hospital stay will be recorded in days.	daily	No
Secondary	Return to function	We will evaluate several aspects of post-surgical recovery and return to normal function. Our major instrument will be the Acute SF 12 health survey.	30 days post operative	No
Secondary	Return to function	We will evaluate several aspects of post-surgical recovery and return to normal function. Our major instrument will be the Acute SF 12 health survey.	90 days post operative	No
Secondary	Consumption of Neuromuscular blocker	Before 45 min to end of surgery rocuronium infusion will be stopped and total consumption of muscle relaxant will be recorded.	day 1	No