Erector Spinae Plane Block, Pain Control, Post-Operative Pain, Chronic
Conditions
Brief summary
Interfascial plane blocks have been developed for analgesia, among which the erector spinae plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal analgesia by spread of local anesthetic into the paravertebral space. Recent studies have contested this idea showing unreliability in the spread of the local anesthetic into the paravertebral space.
Detailed description
Post-operative pain is a significant issue following open heart surgeries and poorly controlled pain can result in significant cardiorespiratory morbidity. Many patients suffer pain both at rest (49%) and on movement (62%) following open heart surgeries via sternotomy and adequate pain management requires closer re-assessment and treatment. The intensity of pain is noted to be higher in the first 48 hours post surgery and hence modalities to control pain may make the greatest difference in the first 2 days after surgery. Enhanced recovery pathways utilizing multimodal analgesia have shown significant analgesic and opioid sparing benefit while minimizing ICU and length of hospital stays. Some multimodal regimens have also incorporated regional blocks but the optimal analgesic regimen remains elusive. The ESP block has been hypothesized to provide truncal anesthesia by spread of local anesthetic into the paravertebral space, but recent studies contest this idea. Bilateral paravertebral blocks can result in higher than acceptable levels of local anesthetic in both cardiac and non-cardiac surgical patients and this may be true following bilateral erector spinae plane (ESP) as well. Hence, the pharmacokinetic profile of administered local anesthetics is necessary given the lack of information about the local anesthetic systemic levels following bilateral ESP.
Interventions
DRUGIntravenous Administration of Lidocaine Post Cardiac Surgery
Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
DRUGAdministration of Lidocaine Post Cardiac Surgery via ESP Catheter
Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
Sponsors
Archit Sharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy. * English speaking
Exclusion criteria
* Emergency surgery * Allergy to medications (ie lidocaine) * BMI less than 20 or greater than 50 * Major liver or kidney dysfunction or other pre-existing major organ dysfunction * Revision cardiac surgery * Surgery via thoracotomy * Off-pump coronary artery bypass * Narcotic dependent (Opioid intake morphine equivalents greater than 10mg/day for more than 3 months * Chronic pain (ie fibromyalgia) * Significant central nervous system or respiratory disease * Hematological disorders or de-ranged coagulation parameters * Psychiatric illness that impedes subject from providing informed consent * Pre-operative neurological deficits * Language barrier * Inability to provide informed consent * Prisoner status * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours | 48 hours post surgical intervention | To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. Cumulative opioid usage amounts required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range. |
| Compare Pain Score Reported by Subject 48 Hours Postoperatively | 48 hours post surgical intervention | Using a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as median and interquartile range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention | First 24 hours post surgical intervention | To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief during the first 24 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range. |
| Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention | From 24 to 48 hours post surgical intervention | To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief 24 and 48 hours post surgical intervention will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range. |
| Pain Score at 24 Hours Postoperatively | 24 hours post surgical intervention | Using a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as Median and interquartile range. |
| Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter. | 24 hours post intervention | All subjects will receive lidocaine via intravenous administration or through erector spinae plane block bilateral catheters. Arterial plasma levels monitoring the concentration of lidocaine will be checked at regular intervals. The number of subjects who reach levels above 5 micrograms/milliliter at the 24-hour timepoint will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours | 36 |
| Intravenous-Administration of Lidocaine Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours | 34 |
| Total | 70 |
Baseline characteristics
| Characteristic | Erector Spinae Plane Block-Administration of Lidocaine | Intravenous-Administration of Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Continuous | 65.36 years STANDARD_DEVIATION 10.1 | 67.94 years STANDARD_DEVIATION 8.28 | 66.61 years STANDARD_DEVIATION 9.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 33 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 32 Participants | 67 Participants |
| Region of Enrollment United States | 36 Participants | 34 Participants | 70 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 30 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Compare Pain Score Reported by Subject 48 Hours Postoperatively
Using a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as median and interquartile range.
Time frame: 48 hours post surgical intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Compare Pain Score Reported by Subject 48 Hours Postoperatively | 3 scored on a scale |
| Intravenous-Administration of Lidocaine | Compare Pain Score Reported by Subject 48 Hours Postoperatively | 2 scored on a scale |
Primary
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. Cumulative opioid usage amounts required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Time frame: 48 hours post surgical intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours | 80.2 Morphine Milligram Equivalents |
| Intravenous-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours | 54.9 Morphine Milligram Equivalents |
Secondary
Pain Score at 24 Hours Postoperatively
Using a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as Median and interquartile range.
Time frame: 24 hours post surgical intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Pain Score at 24 Hours Postoperatively | 3.5 Scored on a scale 0-10 |
| Intravenous-Administration of Lidocaine | Pain Score at 24 Hours Postoperatively | 5.0 Scored on a scale 0-10 |
Secondary
Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.
All subjects will receive lidocaine via intravenous administration or through erector spinae plane block bilateral catheters. Arterial plasma levels monitoring the concentration of lidocaine will be checked at regular intervals. The number of subjects who reach levels above 5 micrograms/milliliter at the 24-hour timepoint will be reported.
Time frame: 24 hours post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter. | 2 Participants |
| Intravenous-Administration of Lidocaine | Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter. | 4 Participants |
Secondary
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention
To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief during the first 24 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Time frame: First 24 hours post surgical intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention | 49.78 Morphine Milligram Equivalents |
| Intravenous-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention | 39.00 Morphine Milligram Equivalents |
Secondary
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention
To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief 24 and 48 hours post surgical intervention will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Time frame: From 24 to 48 hours post surgical intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention | 24.5 Morphine Milligram Equivalents |
| Intravenous-Administration of Lidocaine | Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention | 22.5 Morphine Milligram Equivalents |