N/A
N=116
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Spine Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00840996 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Mean Pain Scores — 4.4; 5.3 verbal response scores — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Scores |
4.4; 5.3 | <0.001 sig |
| PRIMARY Opioid Medication Requirement, mg in IV Morphine Equivalent |
55; 74 | 0.011 sig |
| SECONDARY Number of Participants With Any Major 30-day Post Operative Complications |
2; 5 | 0.049 sig |
| SECONDARY Postoperative Nausea and Vomiting (PONV) |
4; 8; 2; 1 | 0.31 |
| SECONDARY Duration of Hospitalization |
3; 3 | 0.15 |
| SECONDARY 12-item Short Form Survey (SF-12) Physical Health Composite Score |
39; 34 | 0.04 sig |
| SECONDARY 12-item Short Form Survey (SF-12) Physical Health Composite Score |
39; 34 | 0.04 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00840996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.