An interventional study of Bupivacaine 0.25% Injectable Solution and Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg in Post-operative Pain Management, sponsored by Wayne State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Wayne State University · Not applicable, Interventional, and Supportive care
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)
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 200 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Wayne State University is the lead sponsor of 226 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Exclusion Criteria:
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.
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.
Drug: Bupivacaine 0.25% Injectable Solution
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.
Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg
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.
Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.
Post-operative total opioid consumption (oral morphine equivalents)
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Time frame: 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)
Time frame: 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)
Time frame: 12 hours after surgery
Visual analog pain (VAS) scores
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time frame: 24 hours after surgery
Length of hospital stay (LOS)
The days spent in the hospital from surgery to discharge
Time frame: Up to 1 month
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
Time frame: 24 hours
Acetaminophen consumption
Total acetaminophen consumption in mg 24 hr after surgery
Time frame: 24 hours
NSAID (ketorolac) consumption
Total NSAID consumption in mg
Time frame: 24 hours after surgery
Length of ICU stay
Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
Time frame: Up to 1 month
Time to extubation
Time it took for patient to be extubated
Time frame: 24 Hours
Plan to share: No
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Wayne State University