PainPhase 2NCT01930877
Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery
A Phase 2 study testing Lidocaine in people with Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2014
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18-80 yrs;
- American Society of Anesthesiology Physical Status I, II or III; and
- Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery-
Who cannot join
- Allergy to any of the study medications or anesthetic agents used in the study;
- American Society of Anesthesiology physical status IV;
- Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
- History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min
- History of previous spinal fusion or instrumentation;
- Diagnosis of cancer of the spine;
Show all 12Show fewer
- History of surgery for abscess or osteomyelitis;
- History of cardiac dysrhythmia or heart block;
- History of chronic heroin or methadone use;
- Preoperative use of any systemic corticosteroid;
- History of seizure disorder; and
- Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery: A Randomized, Double - Blinded, Placebo Controlled Study
Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.
Read the detailed description
Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine iv bolus followed by infusion
Placebo (normal saline)Other
Normal saline bolus followed by infusion
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Normal saline placebo infusion Receives: Other: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Measured: At 24 hours after surgery
Secondary outcomes (1)
Post operative pain
Measured: for the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
Why it stopped: Withdrawn by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suman Rajagopalan, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930877
- Sponsor's protocol ID
- H-32510
- Status last verified
- Sep 2015
- First submitted
- 26 Aug 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery: A Randomized, Double - Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01930877
- Acronym / sponsor ID
- H-32510
- Conditions
- Pain
- Keywords
- quality of recovery, spine surgery, intravenous lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 29 Aug 2013 (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.
Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.
Detailed description
Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineIntravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr |
| Placebo | Placebo comparator | Other: Placebo (normal saline)Normal saline placebo infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 18-80 yrs;
- American Society of Anesthesiology Physical Status I, II or III; and
- Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery-
Key exclusion criteria (12 listed)
- Allergy to any of the study medications or anesthetic agents used in the study;
- American Society of Anesthesiology physical status IV;
- Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
- History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min
- History of previous spinal fusion or instrumentation;
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 |
|---|---|---|
| LidocaineLidocaine iv bolus followed by infusion | Drug | Lidocaine |
| Placebo (normal saline)Normal saline bolus followed by infusion | Other | Placebo |
Primary outcome
Quality of recovery
Time frame: At 24 hours after surgery
1 secondary outcome
Post operative pain
Time frame: for the first 24 hours after surgery
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 1 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in people with Pain, run by Baylor College of Medicine 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 12 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 1 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of recovery (time frame: At 24 hours after surgery). 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 1 Oct 2015.