Erector Spinae Plane BlockPhase 2NCT04995497
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
A Phase 2 study testing Intravenous Administration of Lidocaine Post Cardiac Surgery and Administration of Lidocaine Post Cardiac Surgery via ESP Catheter in people with Erector Spinae Plane Block and Pain Control, run by Archit Sharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Erector Spinae Plane Block, Pain Control, Post-Operative Pain, Chronic
- What is being tested?
- Intravenous Administration of Lidocaine Post Cardiac Surgery and Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 30 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy.
- English speaking
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
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.
Read the 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.
- Being tested
- Intravenous Administration of Lidocaine Post Cardiac Surgery, Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Administration of Lidocaine Post Cardiac SurgeryDrug
Also called Pain control 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
Administration of Lidocaine Post Cardiac Surgery via ESP CatheterDrug
Also called Pain control post cardiac surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Experimental | 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. Receives: Drug: Administration of Lidocaine Post Cardiac Surgery via ESP Catheter |
| Intravenous-Administration of Lidocaine | Active comparator | 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. Receives: Drug: Intravenous Administration of Lidocaine Post Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours post surgical intervention
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.
Measured: 48 hours post surgical intervention
Secondary outcomes (4)
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.
Measured: First 24 hours post surgical intervention
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.
Measured: From 24 to 48 hours post surgical intervention
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.
Measured: 24 hours post surgical intervention
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.
Measured: 24 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Aug 2021
- Primary completion7 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erector Spinae Plane BlockStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archit Sharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Archit Sharma, University of Iowa
- Investigators
- Archit Sharma, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995497
- Sponsor's protocol ID
- 202009510
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04995497
- Acronym / sponsor ID
- 202009510
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Archit SharmaUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block-Administration of Lidocaine | Experimental | Drug: Administration of Lidocaine Post Cardiac Surgery via ESP CatheterBilateral 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. |
| Intravenous-Administration of Lidocaine | Active comparator | Drug: Intravenous Administration of Lidocaine Post Cardiac SurgerySubject 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy.
- English speaking
Key exclusion criteria (17 listed)
- 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
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 Administration of Lidocaine Post Cardiac SurgeryAlso: Pain control post cardiac surgeryLidocaine 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 | Drug | Intravenous-Administration of Lidocaine |
| Administration of Lidocaine Post Cardiac Surgery via ESP CatheterAlso: Pain control post cardiac surgeryLidocaine 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 | Drug | Erector Spinae Plane Block-Administration of Lidocaine |
Primary outcome
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
Time frame: 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
Time frame: 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.
4 secondary outcomes
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention
Time frame: First 24 hours post surgical intervention
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention
Time frame: From 24 to 48 hours post surgical intervention
Pain Score at 24 Hours Postoperatively
Time frame: 24 hours post surgical intervention
Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.
Time frame: 24 hours post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Archit Sharma, MD principal investigator
University of Iowa
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 Intravenous Administration of Lidocaine Post Cardiac Surgery and Administration of Lidocaine Post Cardiac Surgery via ESP Catheter in people with Erector Spinae Plane Block and Pain Control, run by Archit Sharma 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 2 inclusion and 17 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: finished, as of the sponsor's last update on 9 Apr 2025. 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.
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?
Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours (time frame: 48 hours post surgical intervention). The study lists 2 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 9 Apr 2025.