Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
Conditions
Brief summary
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.
Detailed description
a Phase IV, randomized, triple-blind, placebo-controlled trial with two study groups: postoperative standard of care with opioid patient controlled analgesia (PCA) and IV lidocaine infusion versus postoperative standard of care plus normal saline placebo. Block randomization into one of the two groups will be based on a random table generated using an R-program. Group 1 (Study) will receive intravenous lidocaine during and after posterior spinal fusion for AIS. Group 2 (Control) will receive saline placebo during and after surgery.
Interventions
DRUGIV lidocaine
an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.
DRUGPlacebos
Saline
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study Drug
Intervention model description
a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion. 2. Ages between 12 and 18 years of age. 3. Parent/Guardian capable of providing informed consent for study participation
Exclusion criteria
1. Age \< 12 or \> 18 years old. 2. Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools. 3. Diagnosis of sepsis or infection 4. Diagnosis of primary or metastatic malignancy. 5. Participation in another clinical trial. 6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block. 7. Past or current seizure disorders. 8. Allergy to bupivacaine. 9. Planned anterior approaches for treatment of scoliosis deformity. 10. Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator) 11. Ward of the State children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | up to 6 weeks after surgery | measured in morphine-equivalent dosage (MED) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group will receive intravenous lidocaine during and after posterior spinal fusion for AIS
IV lidocaine: an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication. | 8 |
| Control Group will receive saline placebo during and after surgery.
Placebos: Saline | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.5 Years | 14.4 Years | 13.9 Years |
| BMI | 22.8 kg/m^2 | 23.4 kg/m^2 | 23.1 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Opioid Consumption
measured in morphine-equivalent dosage (MED)
Time frame: up to 6 weeks after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study | Opioid Consumption | 63.7 Morphine ME |
| Control | Opioid Consumption | 119.3 Morphine ME |