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This is a randomized clinical trial in patients undergoing robotic myocardial revascularization with intraoperative extubation. Patients will be randomized into placebo or intrathecal morphine groups to assess postoperative pain scores and patient satisfaction. Patients will also be assessed for side effects from the intervention.
Following Institutional Review Board approval and informed patient consent, 120 patients scheduled for elective robotic myocardial revascularization without cardiopulmonary bypass and anticipated intraoperative tracheal extubation will be studied. Patients will be randomized into one of two groups. Group A (placebo, control group) will receive intrathecal normal saline, Group B (morphine group) intrathecal morphine. All procedures will occur and administered medications given immediately prior to induction of general anesthesia in the operating room. Power analysis indicates that 60 patients per Group is appropriate, as further described below. Inclusion criteria include any patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation. Exclusion criteria include emergency surgery, ejection fraction less than 40%, preoperative use of inotropic agents or intraaortic balloon pump, anticipated use of cardiopulmonary bypass, previous cardiothoracic surgery, anticipated postoperative tracheal intubation, severe pulmonary disease, morbid obesity (BMI >35 kg/m2), severe renal dysfunction (creatinine > 1.5) recent history of opioid abuse, preoperative use of opioids, or any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy).
Routine preoperative data will be collected (see Preoperative Data Sheet). Following intravenous access and routine mild sedation, each patient will be transported to the operating room and assume the sitting position. Following routine skin preparation, a routine lumbar intrathecal injection will be made via a 22-g spinal needle. The injectate will be either morphine (5 mcg/kg, maximum dose of 1 mg) or normal saline. The injectate will be prepared by a co-Investigator not directly involved in patient care. Thus, all preoperative, intraoperative, and postoperative caregivers will be blinded to intrathecal injectate composition (all injectates will be standardized to a total of 1.0 ml). All patients will have port incisions injected with 60 ml of 0.25% bupivacaine by the surgeon after the completion of surgery.
Following intrathecal injection, the patient will then assume the supine position. An arterial catheter will be inserted and general endotracheal anesthesia will be induced. Intraoperative anesthetic technique will be standardized and equivalent between Groups (see Intraoperative Anesthetic Protocol Sheet). The anesthetic protocol will allow tracheal extubation to occur in the operating room immediately after surgery (if clinically indicated).
Surgical technique will not be altered in any way. All patients in both Groups will be operated on by the same surgeon. Routine intraoperative data will be collected (see Intraoperative Data Sheet). In all patients, tracheal extubation will be attempted in the operating room immediately after surgery (if clinically indicated).
Both Groups will receive routine postoperative care and identical postoperative analgesic protocols to assess adequacy of postoperative analgesia (see Postoperative Analgesia Protocol and Postoperative Data Sheets). The American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).15
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal saline. |
|
| Intrathecal morphine | Active Comparator | 60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal morphine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal morphine | Drug | 5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Morphine Consumption | We anticipate that patients in the intervention groups will require less postoperative morphine for pain control. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Patients will score their pain on a visual analog scale of 0-10. The higher the score, the worse the patients reported pain is at that time . | First 48 hours after surgery |
| Patient Satisfaction |
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Inclusion Criteria:
• patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richa Dhawan, MD, MPH | University of Chicago Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 42 patients were randomized to the intrathecal placebo group. This group received a normal saline injected in the spinal spice, prior to surgery. |
| FG001 | Intrathecal Morphine | 37 patients were randomized to the intrathecal morphine group. This group received 5 micrograms/kilogram of intrathecal morphine administered in the spinal space |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 42 patients were randomized to this group |
| BG001 | Intrathecal Morphine | 37 patients were randomized to this group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Morphine Consumption | We anticipate that patients in the intervention groups will require less postoperative morphine for pain control. | Posted | Median | Inter-Quartile Range | Miligram | 24 hours after surgery |
|
Each subject was assessed for adverse events throughout their hospital stay, on average this was 1-2 days per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Intrathecal Saline Group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richa Dhawan | University of Chicago Medicine | 773-702-1000 | rdhawan@dacc.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2019 | Sep 21, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.
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All patients will receive intrathecal intervention and will not know which group they are assigned to. The provider performing the procedure and collecting the data will also be blinded to the intervention assignment.
| Placebo | Drug | Saline intrathecal given in the same manner as the intervention groups. |
|
Patients will take a satisfaction survey prior to discharge, this is measured by calculating a score on a scale. This survey consist of questions that asks about the subjects post-operative experience with pain. Higher reported scores represent worse post-operative subject experience. These are ranked from a 0-10 scale, where 0 is the best experience and 10 meaning the worst experience. Questions being asked how satisfied they were with the results of the pain treatment while hospitalized, least pain in prior 24 hours, worst pain in prior 24 ours, percent time in severe pain, how much pain interfered with different activities, how much pain caused anxiety, depression, fright, helplessness, how severe were symptoms of nausea, drowsiness, itching, dizziness, and percentage pain relief in prior 24 hours.
| 1-3 days after surgery, prior to discharge. |
| Number of Participants With Nausea | Daily evaluation of nausea post-operatively throughout the subjects hospital stay. | Until discharge, 2-3 days after surgery |
| Number of Participants With Respiratory Depression | Opioid related respiratory depression, post-operatively throughout the subjects hospital stay. | During hospital stay |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | KG |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| ASA Physical Status | ASA Physical status is a medical grading system in which it can help predict a patients perioperative risks. The higher the number, the most at risk the patient is and possibility of a worse outcome. ASA grading scale Ranges from 1-6 | Median | Inter-Quartile Range | Units on a scale |
|
| EuroSCORE II | The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. Predicts risk of in-hospital mortality after major cardiac surgery. This is calculated on a score on a scale by entering several different information of the patient into the Euroscore II calculator. These include demographic, lab values, medical history. The higher a patients total score is, the likelihood of post-operative mortality after cardiac surgery is. With a range from 0-21. With 0 meaning there there is no risk of in-hospital mortality after major cardiac surgery and 21 meaning there is a severe high risk. | Mean | Standard Deviation | Scores on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Pain Score | Patients will score their pain on a visual analog scale of 0-10. The higher the score, the worse the patients reported pain is at that time . | Posted | Median | Inter-Quartile Range | score on a scale | First 48 hours after surgery |
|
|
|
| Secondary | Patient Satisfaction | Patients will take a satisfaction survey prior to discharge, this is measured by calculating a score on a scale. This survey consist of questions that asks about the subjects post-operative experience with pain. Higher reported scores represent worse post-operative subject experience. These are ranked from a 0-10 scale, where 0 is the best experience and 10 meaning the worst experience. Questions being asked how satisfied they were with the results of the pain treatment while hospitalized, least pain in prior 24 hours, worst pain in prior 24 ours, percent time in severe pain, how much pain interfered with different activities, how much pain caused anxiety, depression, fright, helplessness, how severe were symptoms of nausea, drowsiness, itching, dizziness, and percentage pain relief in prior 24 hours. | Posted | Median | Inter-Quartile Range | score on a scale | 1-3 days after surgery, prior to discharge. |
|
|
|
| Secondary | Number of Participants With Nausea | Daily evaluation of nausea post-operatively throughout the subjects hospital stay. | Posted | Count of Participants | Participants | Until discharge, 2-3 days after surgery |
|
|
|
| Secondary | Number of Participants With Respiratory Depression | Opioid related respiratory depression, post-operatively throughout the subjects hospital stay. | Posted | Count of Participants | Participants | During hospital stay |
|
|
|
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Morphine | 5 micrograms/kilogram of intrathecal morphine. | 0 | 37 | 0 | 37 | 0 | 37 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |