Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05003765
Other study ID # SPIP_Block
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 6, 2020
Est. completion date May 1, 2022

Study information

Verified date August 2021
Source Wayne State University
Contact Sandeep H Krishnan, MD
Phone (248) 858-6068
Email sakrishna@med.wayne.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients undergoing primary coronary artery bypass grafting Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine 0.25% Injectable Solution
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg
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 mcg
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.

Locations

Country Name City State
United States St. Joseph Mercy Oakland Hospital Pontiac Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative total opioid consumption (oral morphine equivalents) Total Opioid consumption 24 hours post surgery oral moral morphine equivalents 24 hours after the surgery
Primary Visual analog scale (VAS) pain scores Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome) 6 hours after surgery
Primary Visual analog scale (VAS) pain scores Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome) 12 hours after surgery
Primary Visual analog pain (VAS) scores Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome) 24 hours after surgery
Primary Length of hospital stay (LOS) The days spent in the hospital from surgery to discharge Up to 1 month
Secondary 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 24 hours
Secondary Acetaminophen consumption Total acetaminophen consumption in mg 24 hr after surgery 24 hours
Secondary NSAID (ketorolac) consumption Total NSAID consumption in mg 24 hours after surgery
Secondary Length of ICU stay Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit Up to 1 month
Secondary Time to extubation Time it took for patient to be extubated 24 Hours
See also
  Status Clinical Trial Phase
Terminated NCT04191031 - Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty N/A
Not yet recruiting NCT05090735 - Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Transversus Abdominis Plane Block (TAP) Helpful for Post-operative Pain After Coronary Artery Bypass Grafting? N/A
Completed NCT03187379 - Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler Phase 4
Recruiting NCT03510559 - Forearm vs Brachial Plexus Blockade for Routine Hand and Wrist Surgery N/A
Completed NCT05810012 - Comparison of Analgesic Efficacy of PENB Block With FICB in Post Operative Hip Fracture Patients Phase 2