Pain, PostoperativePhase 4NCT03624985
The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
A Phase 4 study testing Intravenous Lidocaine Infusion in people with Pain, Postoperative and Opioid Use, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Intravenous Lidocaine Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 14 Oct 2019
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing one- or two-level posterior lumbar fusion with or without decompression at University of Vermont Medical Center
- 18-75 years of age
- Signed consent form
Who cannot join
- Allergy to lidocaine
- Contraindication to lidocaine, such as substantial hepatic impairment (alanine aminotransferase or aspartate transaminase more than twice normal), renal impairment (serum creatinine >2 mg/dl)
- Seizures or a history of seizure disorder
- Congestive heart failure
- Arrythmias
- Chronic opioid use >45 mg morphine equivalent per day
Show all 10Show fewer
- Trauma patients
- Inter-body fusions
- Severe psychiatric comorbidities
- Planned epidural anesthesia or analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery.
Participants will be recruited by spine surgeons from their pool of patients who are presenting for surgery at University of Vermont Medical Center. If they agree to participate, patients will be assigned at random to receive either an infusion of lidocaine during surgery, or an infusion of saline with 5% dextrose. Subjects will also be asked to complete a 15-item questionnaire that asks about health, quality of life, and level of pain, at three timepoints. Patients will also be asked to rate their level of pain at multiple timepoints after surgery, and we will collect the additionally data from patients' medical records.
Read the detailed description
Lidocaine has analgesic and anti-inflammatory effects. It has been shown to reduce early postoperative pain and nausea. Additionally, lidocaine has been shown to have positive effects in the recovery of bowel function, with a reduction in time to first flatus, first bowel sounds, first bowel movement, and is associated with a reduction of ileus. Because of these facts, lidocaine infusion has become part of enhanced recovery pathways after bowel surgery at our institution and others.
There are few trials examining the use of lidocaine for orthopedic procedures and many of these studies have contradictory adults. An article by Martin et al. found no benefit in pain or recovery after total hip arthroplasty. By contrast, Farag and colleagues found that lidocaine significantly improves postoperative pain after major spine surgery. Additionally, quality of life scores at one and three months after surgery were significantly higher in the lidocaine group. When our Spine Surgery Analgesic Protocol for major spine surgery at University of Vermont Medical Center was revised in 2015, a lidocaine infusion was added to the protocol.
Studies for lidocaine use in minor lumbar surgery are scant. In one study of 50 patients in Korea, patient pain scores and fentanyl consumption were significantly lower in the lidocaine infusion group (1.5 mg/kg bolus plus 2 mg/kg/hr infusion) at 2, 4, 8, 12 and 24 hours after surgery. Of note, the Cleveland Clinic Outcomes group is currently enrolling 440 patients in a study in which half will receive lidocaine and ketamine infusions.
A reduction in opioid use may lead to the potential reduction of opioid-related side effects, such as nausea, constipation, and hyperalgesia, as well as more serious consequences such as respiratory depression and abuse. There is also the possibility of a length of stay reduction which has potential financial benefits.
This is a randomized, controlled, double-blind study involving patients undergoing one- or two-level posterior lumbar instrumented spinal fusion with or without decompression.
The University of Vermont Medical Center operating rooms will be utilized for this investigation. For the study group, we plan to prospectively recruit 140 patients 18-75 years of age. Recruitment will be done by the participating orthopedists and neurosurgeons, from their own patients. After an informed consent discussion, patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min (intervention arm) or no lidocaine (control arm). All patients will receive adequate pain control medication according to their needs. Subjects will complete the 15-question Quality of Recovery assessment at baseline and at 36 and 60 hours after surgery. Using the electronic medical system, the following information with extracted: Total morphine equivalent used in house at 36 hours, total morphine equivalents used at 60 hours, visual analog scale pain scores at 4, 8, 12, 24, 36, and 60 hours, length of stay, incidence of nausea requiring medication, time to first flatus, and time to first bowel movement. Subjects will receive a patient-controlled analgesia pump for the first 36 hours after surgery.
Randomization will be performed by the University of Vermont Medical Center Investigational Pharmacy Drug Service (IDS). IDS will generate a table of random numbers and assign those numbers in a 1:1 ratio of active drug to placebo, in blocks of 4. Following informed consent, a member of the study team will notify IDS, which will prepare syringes for the bolus dose and a bag for the infusion, both containing either active drug or placebo. The syringes and bag will be labeled with the subject's name, medical record number, and randomization number.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Intravenous Lidocaine Infusion, Placebo Infusion
- Keywords
- lidocaine, lumbar spine surgery, postoperative pain, opioid reduction
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Lidocaine InfusionDrug
Also called IV Lidocaine Infusion
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
Placebo InfusionDrug
Also called Placebo, Control, Comparator
Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Lidocaine Infusion | Experimental | Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min. Receives: Drug: Intravenous Lidocaine Infusion |
| Placebo Infusion | Placebo comparator | Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose. Receives: Drug: Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine equivalent consumed at 24 hours after surgery
Subjects will receive a patient-controlled analgesia pump for the first 24 hours after surgery. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents.
Measured: 24 hours postoperatively
Secondary outcomes (11)
Total morphine equivalent consumed at 48 hours after surgery
Electronic medical records will be reviewed to total opioids received after the patient-controlled analgesia pump is discontinued. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents.
Measured: 48 hours postoperatively
Pain score 4 hours post-operation
Visual analog scale pain scores 4 hours after the end of the operation.
The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The patient marks a point on the line that matches the amount of pain they feel.
0 = no pain 100 = worst pain imaginable
Measured: 4 hours postoperatively
Pain score 10 hours post-operation
Visual analog scale pain scores 10 hours after the end of the operation.
The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The patient marks a point on the line that matches the amount of pain they feel.
0 = no pain 100 = worst pain imaginable
Measured: 10 hours postoperatively
Pain score 24 hours post-operation
Visual analog scale pain scores 24 hours after the end of the operation.
The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The patient marks a point on the line that matches the amount of pain they feel.
0 = no pain 100 = worst pain imaginable
Measured: 24 hours postoperatively
Pain score 48 hours post-operation
Visual analog scale pain scores 48 hours after the end of the operation.
The visual analog scale is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The patient marks a point on the line that matches the amount of pain they feel.
0 = no pain 100 = worst pain imaginable
Measured: 48 hours postoperatively
Quality of Recovery Score 36 hours post-operation
Subjects will complete the 15-question Quality of Recovery 36 hours after the end of surgery. Scores will be compared to the baseline taken in the pre-operative hold area.
Measured: 36 hours postoperatively
Quality of Recovery Score 48 hours post-operation
Subjects will complete the 15-question Quality of Recovery 48 hours after the end of surgery. Scores will be compared to the baseline taken in the pre-operative hold area.
Measured: 48 hours postoperatively
Length of Stay
Length of stay in the hospital, defined as time between admission and discharge. Unit of measure: Days.
Measured: During hospitalization, approximately 5 days
Incidence of nausea
A count of the incidences of treatment of nausea with medication.
Measured: During hospitalization, approximately 5 days
Time to first flatus
Time of first flatus will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours.
Measured: 96 hours postoperatively
Time to first bowel movement
Time of first bowel movement will be recorded by floor nurses and extracted from the electronic medical record. Unit of measure: Hours.
Measured: 96 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start4 Jun 2018
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Why it stopped: Subjects had a high dropout rate. Of 61 consented, 24 did not participate. Reasons: Surgical cancellations; changing procedure type after consent; and staffing issues. The dropout rate of 39% was considered a barrier to publication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, double-blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Dominick, University of Vermont Medical Center
- Investigators
- Timothy Dominick, MD, Principal investigator, AnesthesiologistDavid Lunardini, MD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624985
- Sponsor's protocol ID
- CHRMS 18-0111
- Status last verified
- Jan 2023
- First submitted
- 13 Jun 2018
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
PubMed 10969322Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
PubMed 18844267Martin F, Cherif K, Gentili ME, Enel D, Abe E, Alvarez JC, Mazoit JX, Chauvin M, Bouhassira D, Fletcher D. Lack of impact of intravenous lidocaine on analgesia, functional recovery, and nociceptive pain threshold after total hip arthroplasty. Anesthesiology. 2008 Jul;109(1):118-23. doi: 10.1097/ALN.0b013e31817b5a9b.
PubMed 18580181Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
PubMed 23681143Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
PubMed 24216403
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT03624985
- Acronym / sponsor ID
- CHRMS 18-0111
- Conditions
- Pain, Postoperative, Opioid Use
- Keywords
- lidocaine, lumbar spine surgery, postoperative pain, opioid reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subjects had a high dropout rate. Of 61 consented, 24 did not participate. Reasons: Surgical cancellations; changing procedure type after consent; and staffing issues. The dropout rate of 39% was considered a barrier to publication.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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 determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery.
Participants will be recruited by spine surgeons from their pool of patients who are presenting for surgery at University of Vermont Medical Center. If they agree to participate, patients will be assigned at random to receive either an infusion of lidocaine during surgery, or an infusion of saline with 5% dextrose. Subjects will also be asked to complete a 15-item questionnaire that asks about health, quality of life, and level of pain, at three timepoints. Patients will also be asked to rate their level of pain at multiple timepoints after surgery, and we will collect the additionally data from patients' medical records.
Detailed description
Lidocaine has analgesic and anti-inflammatory effects. It has been shown to reduce early postoperative pain and nausea. Additionally, lidocaine has been shown to have positive effects in the recovery of bowel function, with a reduction in time to first flatus, first bowel sounds, first bowel movement, and is associated with a reduction of ileus. Because of these facts, lidocaine infusion has become part of enhanced recovery pathways after bowel surgery at our institution and others.
There are few trials examining the use of lidocaine for orthopedic procedures and many of these studies have contradictory adults. An article by Martin et al. found no benefit in pain or recovery after total hip arthroplasty. By contrast, Farag and colleagues found that lidocaine significantly improves postoperative pain after major spine surgery. Additionally, quality of life scores at one and three months after surgery were significantly higher in the lidocaine group. When our Spine Surgery Analgesic Protocol for major spine surgery at University of Vermont Medical Center was revised in 2015, a lidocaine infusion was added to the protocol.
Studies for lidocaine use in minor lumbar surgery are scant. In one study of 50 patients in Korea, patient pain scores and fentanyl consumption were significantly lower in the lidocaine infusion group (1.5 mg/kg bolus plus 2 mg/kg/hr infusion) at 2, 4, 8, 12 and 24 hours after surgery. Of note, the Cleveland Clinic Outcomes group is currently enrolling 440 patients in a study in which half will receive lidocaine and ketamine infusions.
A reduction in opioid use may lead to the potential reduction of opioid-related side effects, such as nausea, constipation, and hyperalgesia, as well as more serious consequences such as respiratory depression and abuse. There is also the possibility of a length of stay reduction which has potential financial benefits.
This is a randomized, controlled, double-blind study involving patients undergoing one- or two-level posterior lumbar instrumented spinal fusion with or without decompression.
The University of Vermont Medical Center operating rooms will be utilized for this investigation. For the study group, we plan to prospectively recruit 140 patients 18-75 years of age. Recruitment will be done by the participating orthopedists and neurosurgeons, from their own patients. After an informed consent discussion, patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min (intervention arm) or no lidocaine (control arm). All patients will receive adequate pain control medication according to their needs. Subjects will complete the 15-question Quality of Recovery assessment at baseline and at 36 and 60 hours after surgery. Using the electronic medical system, the following information with extracted: Total morphine equivalent used in house at 36 hours, total morphine equivalents used at 60 hours, visual analog scale pain scores at 4, 8, 12, 24, 36, and 60 hours, length of stay, incidence of nausea requiring medication, time to first flatus, and time to first bowel movement. Subjects will receive a patient-controlled analgesia pump for the first 36 hours after surgery.
Randomization will be performed by the University of Vermont Medical Center Investigational Pharmacy Drug Service (IDS). IDS will generate a table of random numbers and assign those numbers in a 1:1 ratio of active drug to placebo, in blocks of 4. Following informed consent, a member of the study team will notify IDS, which will prepare syringes for the bolus dose and a bag for the infusion, both containing either active drug or placebo. The syringes and bag will be labeled with the subject's name, medical record number, and randomization number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Intravenous Lidocaine Infusion | Experimental | Drug: Intravenous Lidocaine InfusionPatients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min. |
| Placebo Infusion | Placebo comparator | Drug: Placebo InfusionPatients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing one- or two-level posterior lumbar fusion with or without decompression at University of Vermont Medical Center
- 18-75 years of age
- Signed consent form
Key exclusion criteria (10 listed)
- Allergy to lidocaine
- Contraindication to lidocaine, such as substantial hepatic impairment (alanine aminotransferase or aspartate transaminase more than twice normal), renal impairment (serum creatinine >2 mg/dl)
- Seizures or a history of seizure disorder
- Congestive heart failure
- Arrythmias
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 |
|---|---|---|
| Intravenous Lidocaine InfusionAlso: IV Lidocaine InfusionPatients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min. | Drug | Intravenous Lidocaine Infusion |
| Placebo InfusionAlso: Placebo, Control, ComparatorPatients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose | Drug | Placebo Infusion |
Primary outcome
Total morphine equivalent consumed at 24 hours after surgery
Time frame: 24 hours postoperatively
Subjects will receive a patient-controlled analgesia pump for the first 24 hours after surgery. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents.
11 secondary outcomes
Total morphine equivalent consumed at 48 hours after surgery
Time frame: 48 hours postoperatively
Pain score 4 hours post-operation
Time frame: 4 hours postoperatively
Pain score 10 hours post-operation
Time frame: 10 hours postoperatively
Pain score 24 hours post-operation
Time frame: 24 hours postoperatively
Pain score 48 hours post-operation
Time frame: 48 hours postoperatively
Quality of Recovery Score 36 hours post-operation
Time frame: 36 hours postoperatively
Quality of Recovery Score 48 hours post-operation
Time frame: 48 hours postoperatively
Length of Stay
Time frame: During hospitalization, approximately 5 days
Incidence of nausea
Time frame: During hospitalization, approximately 5 days
Time to first flatus
Time frame: 96 hours postoperatively
Time to first bowel movement
Time frame: 96 hours postoperatively
Results and safety
The study was stopped early (reason given: Subjects had a high dropout rate. Of 61 consented, 24 did not participate. Reasons: Surgical cancellations; changing procedure type after consent; and staffing issues. The dropout rate of 39% was considered a barrier to publication.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 10969322Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
- Background: PubMed 18844267Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
- Background: PubMed 18580181Martin F, Cherif K, Gentili ME, Enel D, Abe E, Alvarez JC, Mazoit JX, Chauvin M, Bouhassira D, Fletcher D. Lack of impact of intravenous lidocaine on analgesia, functional recovery, and nociceptive pain threshold after total hip arthroplasty. Anesthesiology. 2008 Jul;109(1):118-23. doi: 10.1097/ALN.0b013e31817b5a9b.
- Background: PubMed 23681143Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
- Background: PubMed 24216403Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
- Individual participant dataSharing planned: No
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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.
Timothy Dominick, MD principal investigator
Anesthesiologist
David Lunardini, MD principal investigator
Orthopedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Lidocaine Infusion in people with Pain, Postoperative and Opioid Use, run by University of Vermont Medical Center 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 10 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: stopped early, as of the sponsor's last update on 31 Jan 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Subjects had a high dropout rate. Of 61 consented, 24 did not participate. Reasons: Surgical cancellations; changing procedure type after consent; and staffing issues. The dropout rate of 39% was considered a barrier to publication.). Results are not available in the source record.
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?
Total morphine equivalent consumed at 24 hours after surgery (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624985, which also lists 5 linked publications.
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 31 Jan 2023.