Post-operative Pain ManagementNCT05003765
Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Adjuvants Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?
A study testing Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg in people with Post-operative Pain Management, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the addition of the superficial parasternal intercostal plane (SPIP) block alone (30cc of 0.25% bupivacaine) or plus Magnesium (200mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300mcg) as adjuvants can improve post-operative pain in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-operative Pain Management
- What is being tested?
- Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 1 May 2022
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary coronary artery bypass grafting
Who cannot join
- Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.)
- Patients with significant platelet dysfunction
- Infection at site for regional anesthesia
- Allergy to local anesthetics
- Severe aortic stenosis
- Severe mitral stenosis
- Sepsis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Lena Anderson, 248-858-6068, LeAnders@med.wayne.edu
About this study
Official title: Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Local Anesthetic Alone and Local Anesthetic With Adjuvants Helpful in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?
The purpose of this study is to determine whether the addition of the superficial parasternal intercostal plane (SPIP) block alone (30cc of 0.25% bupivacaine) or plus Magnesium (200mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300mcg) as adjuvants can improve post-operative pain in patients undergoing cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG)
Read the detailed description
Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control can have adverse pathophysiologic consequences, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for formation of clots in a blood vessels (thromboembolism). These adverse events may result in greater perioperative morbidity and mortality. Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains an issue.
Regional anesthesia is used to block sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.
Ultrasound has revolutionized regional anesthesia by allowing real-time visualization of anatomical structures, needle advancement and local anesthetic (LA) spread. This has led not only to refinement of existing techniques, but also the introduction of new ones.
In particular, ultrasound has been critical in the development of fascial plane blocks, in which local anesthetic (LA) is injected into a tissue plane rather than directly around nerves. These blocks are believed to work via passive spread of LA to nerves traveling within that tissue plane, or to adjacent tissue compartments containing nerves.
Although research into these techniques is still at an early stage, the available evidence indicates that they are effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics, rather than as sole anesthetic techniques. Catheters may be beneficial in situations where moderate-severe pain is expected for >12 hours, although the optimal dosing regimen requires further investigation.
In this study the investigators will focus on the superficial parasternal-intercostal plane (SPIP) block, which is among the anteromedial chest wall (near sternum) blocks and was first performed by Raza et al. and Ohgoshi et al.
The investigators will be assessing whether the addition of SPIP block (alone or plus adjuvants) will decrease the visual analog scale (VAS) pain scores in the first 24 hours after surgery, decrease post-operative total opioid consumption (oral morphine equivalents), decrease total acetaminophen and ketorolac consumption, decrease post-operative nausea and vomiting (PONV), decrease length of the ICU stay, decrease time to extubation, and decrease length of hospital stay in comparison to when SPIP block is not administered.
- Conditions
- Post-operative Pain Management
- Being tested
- Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
- Keywords
- coronary artery bypass grafting, superficial parasternal intercostal plane block , opioid consumption, magnesium, buprenorphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mgDrug
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcgDrug
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.
| Study group | Role | What they receive |
|---|---|---|
| Saline injection (CTRL) | No intervention | Arm 1- 50 Patients-Control Group (CTRL): No Block (Saline) Post-operatively patients will receive 20 mL of Saline (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. |
| SPIP Block | Experimental | Arm 2-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| SPIP Block + Magnesium | Experimental | Arm 3-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine + 200mg of magnesium sulfate (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. Receives: Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg |
| SPIP Block + Magnesium + Buprenorphine | Experimental | Arm 4-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine+ 200mg of magnesium sulfate + buprenorphine (300mcg) (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. Receives: Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative total opioid consumption (oral morphine equivalents)
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Measured: 24 hours after the surgery
Visual analog scale (VAS) pain scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Measured: 6 hours after surgery
Visual analog scale (VAS) pain scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Measured: 12 hours after surgery
Visual analog pain (VAS) scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Measured: 24 hours after surgery
Length of hospital stay (LOS)
The days spent in the hospital from surgery to discharge
Measured: Up to 1 month
Secondary outcomes (5)
Incidence of post-operation nausea and vomiting (PONV)
The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Measured: 24 hours
Acetaminophen consumption
Total acetaminophen consumption in mg 24 hr after surgery
Measured: 24 hours
NSAID (ketorolac) consumption
Total NSAID consumption in mg
Measured: 24 hours after surgery
Length of ICU stay
Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
Measured: Up to 1 month
Time to extubation
Time it took for patient to be extubated
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start6 Aug 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Pain ManagementStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will consist of 4 arms (groups): Control Group (CTRL): No Block (Saline) Treatment Group1 (TRT1): SPIP Block with bupivacaine Treatment Group 2 (TRT2): SPIP Block with Bupivacaine +Magnesium as Adjuvant Treatment Group 3 (TRT3): SPIP Block with Bupivacaine +Magnesium + Buprenorphine both as Adjuvant Patients are assigned randomly to each group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Krishnan, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003765
- Sponsor's protocol ID
- SPIP_Block
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Local Anesthetic Alone and Local Anesthetic With Adjuvants Helpful in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?
- ClinicalTrials.gov ID
- NCT05003765
- Acronym / sponsor ID
- SPIP_Block
- Conditions
- Post-operative Pain Management
- Keywords
- coronary artery bypass grafting, superficial parasternal intercostal plane block , opioid consumption, magnesium, buprenorphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 12 Aug 2021 (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 the addition of the superficial parasternal intercostal plane (SPIP) block alone (30cc of 0.25% bupivacaine) or plus Magnesium (200mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300mcg) as adjuvants can improve post-operative pain in patients undergoing cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG)
Detailed description
Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control can have adverse pathophysiologic consequences, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for formation of clots in a blood vessels (thromboembolism). These adverse events may result in greater perioperative morbidity and mortality. Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains an issue.
Regional anesthesia is used to block sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques.
Ultrasound has revolutionized regional anesthesia by allowing real-time visualization of anatomical structures, needle advancement and local anesthetic (LA) spread. This has led not only to refinement of existing techniques, but also the introduction of new ones.
In particular, ultrasound has been critical in the development of fascial plane blocks, in which local anesthetic (LA) is injected into a tissue plane rather than directly around nerves. These blocks are believed to work via passive spread of LA to nerves traveling within that tissue plane, or to adjacent tissue compartments containing nerves.
Although research into these techniques is still at an early stage, the available evidence indicates that they are effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics, rather than as sole anesthetic techniques. Catheters may be beneficial in situations where moderate-severe pain is expected for >12 hours, although the optimal dosing regimen requires further investigation.
In this study the investigators will focus on the superficial parasternal-intercostal plane (SPIP) block, which is among the anteromedial chest wall (near sternum) blocks and was first performed by Raza et al. and Ohgoshi et al.
The investigators will be assessing whether the addition of SPIP block (alone or plus adjuvants) will decrease the visual analog scale (VAS) pain scores in the first 24 hours after surgery, decrease post-operative total opioid consumption (oral morphine equivalents), decrease total acetaminophen and ketorolac consumption, decrease post-operative nausea and vomiting (PONV), decrease length of the ICU stay, decrease time to extubation, and decrease length of hospital stay in comparison to when SPIP block is not administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This study will consist of 4 arms (groups): Control Group (CTRL): No Block (Saline) Treatment Group1 (TRT1): SPIP Block with bupivacaine Treatment Group 2 (TRT2): SPIP Block with Bupivacaine +Magnesium as Adjuvant Treatment Group 3 (TRT3): SPIP Block with Bupivacaine +Magnesium + Buprenorphine both as Adjuvant Patients are assigned randomly to each group.
| Arm | Type | Receives |
|---|---|---|
| Saline injection (CTRL) | No intervention | –Arm 1- 50 Patients-Control Group (CTRL): No Block (Saline) Post-operatively patients will receive 20 mL of Saline (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. |
| SPIP Block | Experimental | Drug: Bupivacaine 0.25% Injectable SolutionArm 2-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. |
| SPIP Block + Magnesium | Experimental | Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mgArm 3-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine + 200mg of magnesium sulfate (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. |
| SPIP Block + Magnesium + Buprenorphine | Experimental | Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcgArm 4-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine+ 200mg of magnesium sulfate + buprenorphine (300mcg) (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary coronary artery bypass grafting
Key exclusion criteria (7 listed)
- Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.)
- Patients with significant platelet dysfunction
- Infection at site for regional anesthesia
- Allergy to local anesthetics
- Severe aortic stenosis
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionInjection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. | Drug | SPIP Block |
| Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mgInjection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant. | Drug | SPIP Block + Magnesium |
| Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcgInjection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants. | Drug | SPIP Block + Magnesium + Buprenorphine |
Primary outcome
Post-operative total opioid consumption (oral morphine equivalents)
Time frame: 24 hours after the surgery
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Visual analog scale (VAS) pain scores
Time frame: 6 hours after surgery
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain scores
Time frame: 12 hours after surgery
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog pain (VAS) scores
Time frame: 24 hours after surgery
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Length of hospital stay (LOS)
Time frame: Up to 1 month
The days spent in the hospital from surgery to discharge
5 secondary outcomes
Incidence of post-operation nausea and vomiting (PONV)
Time frame: 24 hours
Acetaminophen consumption
Time frame: 24 hours
NSAID (ketorolac) consumption
Time frame: 24 hours after surgery
Length of ICU stay
Time frame: Up to 1 month
Time to extubation
Time frame: 24 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg in people with Post-operative Pain Management, run by Wayne State University 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandeep H Krishnan, MD ((248) 858-6068, sakrishna@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative total opioid consumption (oral morphine equivalents) (time frame: 24 hours after the surgery). The study lists 5 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 12 Aug 2021.