Back PainNCT01043211
Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery
A study testing Lidocaine Hydrochoride Injection, without epinephrine and Normal Saline in people with Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to generate further insight into the role and effectiveness of the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Lidocaine Hydrochoride Injection, without epinephrine and Normal Saline
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years to 80 years of age
- American Society of Anesthesiologists 1-3 status
- Undergoing lumbar laminectomy between levels L1 and S1 for decompression of degenerative lumbar canal stenosis but without fusion or internal fixation performed
Who cannot join
- American Society of Anesthesiologists 4 status
- Previous spinal fusion surgery but patient may have undergone previous lumbar laminectomy or lumbar open discectomy
- Morbid obesity (BMI > 40)
- Diagnosis of spinal metastatic cancer
- Presence of a severe or systemic bacterial infection
- Allergy to an amide local anesthetic or morphine sulfate
Show all 19Show fewer
- History of a seizure disorder
- History of atrial or ventricular arrhythmia
- History of autonomic dysfunction (e.g., dysautonomia of diabetes)
- History of renal dysfunction, liver dysfunction or congestive heart failure
- History of substance abuse disorder
- History of major psychiatric disorder (e.g., depression, bipolar disorder, Axis II personality disorder, schizophrenia)
- Chronic opioid use of greater than 100 mg/day of morphine equivalents within 30 days prior to surgery
- Current use of a corticosteroid
- Use of a non-steroidal anti-inflammatory drug (NSAID), including low dose aspirin within the past 5 days
- Use of an arrhythmic drug within the past 7 days
- Current administration of a known potent CYP1A2 inhibitor, including zileuton (Zyflo), ciprofloxacin, enoxacin or any other fluoroquinolone antibiotic, amiodarone, mexiletine, propafenone, verapamil, cimetidine (Tagamet), famotidine (Pepcid), oral contraceptives, acyclovir (Zovirax) and ticlopidine (Ticlid) (Horn \& Hansten, 2008).
- Current administration of a known potent CYP3A4 inhibitor, including erythromycin, clarithromycin, azole antifungal (ketoconazole, fluconazole), verapamil, diltiazem, and grapefruit juice (Scuderi et al., 2006).
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery: A Randomized Controlled Trial
The purpose of this study is to generate further insight into the role and effectiveness of the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine surgery. The effect of perioperative intravenous lidocaine infusion on postoperative rehabilitation and the inflammatory response will also be examined.
Read the detailed description
Inadequate pain control after spine surgery in adults can result in increased patient morbidity and length of hospital stay, whereas improved postoperative pain control has been demonstrated to have numerous physiologic benefits and to reduce postoperative complications. When administered systemically, the amide local anesthetic lidocaine has potent anti-inflammatory properties, including inhibition of the arachidonic acid cascade and production of eicosanoids and prostaglandins. Previous studies have confirmed that the continuous intravenous administration of lidocaine during and after abdominal surgery in adults improves patient rehabilitation (specifically, pain intensity, duration of ileus, incidence of nausea and vomiting), and shortens hospital stay. The beneficial anti-inflammatory properties versus untoward side effects of the local anesthetics appear superior to steroids and the non-steroidal anti-inflammatory drugs (NSAIDs). Moreover, concern and controversy exists regarding the adverse effects of NSAIDs on bone healing, particularly in adults undergoing spine surgery.
No study to date has investigated the efficacy of a continuous perioperative lidocaine infusion in the adult spine surgery population. Therefore, in this prospective, randomized, controlled trial, we will evaluate the analgesic efficacy, anti-inflammatory properties, and rehabilitation pattern with a continuous, perioperative intravenous infusion of lidocaine versus a normal saline placebo in adult patients undergoing a decompressive lumbar laminectomy for spinal canal stenosis. Subjects enrolled in this study will receive a standardized general anesthetic that is consistent with our present clinical practice. The study participants will be randomized to receive both a perioperative bolus (2 mg/kg) and subsequent intravenous infusion (3 mg/kg/hr) of the amide local anesthetic lidocaine or a normal saline placebo at an equal volume per hour. The study infusion will be continued for 90 minutes after surgery. All patients will receive ample and adequate intravenous doses of an opioid (morphine sulfate) to reduce their pain intensity to acceptable levels. Pain intensity, opioid requirements, opioid-related side effects, and both the immediate and sustained rehabilitation pattern will be assessed. In addition to plasma lidocaine levels in the active drug group, plasma C-reactive protein, cortisol, and cytokine levels (e.g., IL-6, IL-10 and TNF-α) will be obtained at a series of perioperative time points in all study patients. Postoperative cytokine levels will also be measured in the surgical drainage fluid.
- Conditions
- Back Pain
- Being tested
- Lidocaine Hydrochoride Injection, without epinephrine, Normal Saline
- Keywords
- Back Pain, Lidocaine
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochoride Injection, without epinephrineDrug
Also called Xylocaine
A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. Immediately thereafter, lidocaine (1%, 10 mg/ml) will be administered on a standardized 0.3 ml/hr/kg (3 mg/kg/hr, maximum 200 mg/hr = 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the lidocaine infusion will be decreased by 50% to 0.15 ml/hr/kg (1.5 mg/kg/hr, maximum 100 mg/hr = 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
Normal SalineDrug
A standardized 0.2 ml/kg intravenous bolus dose of preservative-free normal saline will be given after anesthetic induction but prior to skin incision. Immediately thereafter, normal saline will be administered on an equal 0.3 ml/hr/kg (maximum 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the normal saline infusion will be decreased by 50% to 0.15 ml/hr/kg (maximum 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).
Normal SalineDrug
A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postanesthesia care unit(PACU)admission duration (in minutes)
Measured: Assessed after discharge from PACU
Post extubation requirement for intravenous fentanyl in operating room (Y/N and mcg/kg)
Measured: Post extubation
Time to first nurse administered morphine dose after PACU admission (in minutes)
Measured: Assessed after PACU admission
Total dose of fentanyl administered intraoperatively (mcg/kg) and in the PACU (mcg/kg)
Measured: Measured post op
Total amount of mophine administered/PCA pump demands and doses and ratio of PCA demands/doses
Measured: 48-72 hours postoperative period
Self reported VAS pain scores (on a 0-100 scale)
Measured: Obtained on admissions to and upon discharge from PCAU, every 4 hours thereafter for the first 48 to 72 hours postoperatively, and at time of initial postoperative mobilization
Secondary outcomes (4)
Side effect analysis
Measured: Measurements of side effect analysis will be done postoperatively
Pain Intensity Questionnaires
Measured: BPI-SF completed at time of initial and subsequent postop visits, Roland Morris Back Pain Questionnaire completed postop and 12-14 days, 3 mos, 6 mos, 12 mos, and 24 mos postop as compared to baseline value
Length of hospital stay
Measured: From admission to discharge
Post rehab analysis
Measured: Time to first liquid oral intake, time to initial mobilization, time to discontinuation of study solution infusion, time to discharge order, and to time to actual discharge home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionMar 2014
Why it stopped: Did not have the research staff necessary to follow through with this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Vetter, M.D., M.P.H, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043211
- Sponsor's protocol ID
- F091105002
- Status last verified
- Jan 2015
- First submitted
- 28 Dec 2009
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01043211
- Acronym / sponsor ID
- F091105002
- Conditions
- Back Pain
- Keywords
- Back Pain, Lidocaine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not have the research staff necessary to follow through with this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to generate further insight into the role and effectiveness of the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine surgery. The effect of perioperative intravenous lidocaine infusion on postoperative rehabilitation and the inflammatory response will also be examined.
Detailed description
Inadequate pain control after spine surgery in adults can result in increased patient morbidity and length of hospital stay, whereas improved postoperative pain control has been demonstrated to have numerous physiologic benefits and to reduce postoperative complications. When administered systemically, the amide local anesthetic lidocaine has potent anti-inflammatory properties, including inhibition of the arachidonic acid cascade and production of eicosanoids and prostaglandins. Previous studies have confirmed that the continuous intravenous administration of lidocaine during and after abdominal surgery in adults improves patient rehabilitation (specifically, pain intensity, duration of ileus, incidence of nausea and vomiting), and shortens hospital stay. The beneficial anti-inflammatory properties versus untoward side effects of the local anesthetics appear superior to steroids and the non-steroidal anti-inflammatory drugs (NSAIDs). Moreover, concern and controversy exists regarding the adverse effects of NSAIDs on bone healing, particularly in adults undergoing spine surgery.
No study to date has investigated the efficacy of a continuous perioperative lidocaine infusion in the adult spine surgery population. Therefore, in this prospective, randomized, controlled trial, we will evaluate the analgesic efficacy, anti-inflammatory properties, and rehabilitation pattern with a continuous, perioperative intravenous infusion of lidocaine versus a normal saline placebo in adult patients undergoing a decompressive lumbar laminectomy for spinal canal stenosis. Subjects enrolled in this study will receive a standardized general anesthetic that is consistent with our present clinical practice. The study participants will be randomized to receive both a perioperative bolus (2 mg/kg) and subsequent intravenous infusion (3 mg/kg/hr) of the amide local anesthetic lidocaine or a normal saline placebo at an equal volume per hour. The study infusion will be continued for 90 minutes after surgery. All patients will receive ample and adequate intravenous doses of an opioid (morphine sulfate) to reduce their pain intensity to acceptable levels. Pain intensity, opioid requirements, opioid-related side effects, and both the immediate and sustained rehabilitation pattern will be assessed. In addition to plasma lidocaine levels in the active drug group, plasma C-reactive protein, cortisol, and cytokine levels (e.g., IL-6, IL-10 and TNF-α) will be obtained at a series of perioperative time points in all study patients. Postoperative cytokine levels will also be measured in the surgical drainage fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years to 80 years of age
- American Society of Anesthesiologists 1-3 status
- Undergoing lumbar laminectomy between levels L1 and S1 for decompression of degenerative lumbar canal stenosis but without fusion or internal fixation performed
Key exclusion criteria (19 listed)
- American Society of Anesthesiologists 4 status
- Previous spinal fusion surgery but patient may have undergone previous lumbar laminectomy or lumbar open discectomy
- Morbid obesity (BMI > 40)
- Diagnosis of spinal metastatic cancer
- Presence of a severe or systemic bacterial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Hydrochoride Injection, without epinephrineAlso: XylocaineA standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. Immediately thereafter, lidocaine (1%, 10 mg/ml) will be administered on a standardized 0.3 ml/hr/kg (3 mg/kg/hr, maximum 200 mg/hr = 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the lidocaine infusion will be decreased by 50% to 0.15 ml/hr/kg (1.5 mg/kg/hr, maximum 100 mg/hr = 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU). | Drug | – |
| Normal SalineA standardized 0.2 ml/kg intravenous bolus dose of preservative-free normal saline will be given after anesthetic induction but prior to skin incision. Immediately thereafter, normal saline will be administered on an equal 0.3 ml/hr/kg (maximum 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the normal saline infusion will be decreased by 50% to 0.15 ml/hr/kg (maximum 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU). | Drug | – |
| Normal SalineA standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. | Drug | – |
Primary outcome
Postanesthesia care unit(PACU)admission duration (in minutes)
Time frame: Assessed after discharge from PACU
Post extubation requirement for intravenous fentanyl in operating room (Y/N and mcg/kg)
Time frame: Post extubation
Time to first nurse administered morphine dose after PACU admission (in minutes)
Time frame: Assessed after PACU admission
Total dose of fentanyl administered intraoperatively (mcg/kg) and in the PACU (mcg/kg)
Time frame: Measured post op
Total amount of mophine administered/PCA pump demands and doses and ratio of PCA demands/doses
Time frame: 48-72 hours postoperative period
Self reported VAS pain scores (on a 0-100 scale)
Time frame: Obtained on admissions to and upon discharge from PCAU, every 4 hours thereafter for the first 48 to 72 hours postoperatively, and at time of initial postoperative mobilization
4 secondary outcomes
Side effect analysis
Time frame: Measurements of side effect analysis will be done postoperatively
Pain Intensity Questionnaires
Time frame: BPI-SF completed at time of initial and subsequent postop visits, Roland Morris Back Pain Questionnaire completed postop and 12-14 days, 3 mos, 6 mos, 12 mos, and 24 mos postop as compared to baseline value
Length of hospital stay
Time frame: From admission to discharge
Post rehab analysis
Time frame: Time to first liquid oral intake, time to initial mobilization, time to discontinuation of study solution infusion, time to discharge order, and to time to actual discharge home
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Vetter, M.D., M.P.H principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Hydrochoride Injection, without epinephrine and Normal Saline in people with Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postanesthesia care unit(PACU)admission duration (in minutes) (time frame: Assessed after discharge from PACU). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.