- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840996
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
|
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
|
ACTIVE_COMPARATOR: Lidocaine
Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Scores
Time Frame: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).
|
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
Time Frame: through postoperative day 2 (or discharge, if earlier)
|
Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents
|
through postoperative day 2 (or discharge, if earlier)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Any Major 30-day Post Operative Complications
Time Frame: 30 days after surgery
|
The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.
|
30 days after surgery
|
Postoperative Nausea and Vomiting (PONV)
Time Frame: post op day one and two or till hospital discharge
|
Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.
|
post op day one and two or till hospital discharge
|
Duration of Hospitalization
Time Frame: At discharge
|
Length of hospital stay will be recorded in days.
|
At discharge
|
12-item Short Form Survey (SF-12) Physical Health Composite Score
Time Frame: 30 days post operative
|
Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
|
30 days post operative
|
12-item Short Form Survey (SF-12) Physical Health Composite Score
Time Frame: 90 days post operative
|
Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
|
90 days post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 08-209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spine Surgery
-
Rothman Institute OrthopaedicsEnrolling by invitation
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
University Hospital, AachenCompleted
-
University of WashingtonHospira, now a wholly owned subsidiary of PfizerCompletedSpine SurgeryUnited States
-
Rigshospitalet, DenmarkCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruiting
-
King Khalid University HospitalNot yet recruitingSpine SurgerySaudi Arabia
-
Advanced Scanners Inc.Enrolling by invitation
-
Brigham and Women's HospitalCompleted
-
Albany Medical CollegeUnknown
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States