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Extract Of Fresh Opium Poppy (1:2.2-2.7), Extraction Solvent: Ethanol 31.2 % (M/M)

This article discusses a clinical trial investigating the use of spinal analgesia with morphine and bupivacaine in patients undergoing robot-assisted laparoscopic upper urinary tract surgery. The study aims to evaluate the effects of this approach on postoperative recovery, pain management, and other important outcomes. The trial, known as SMILe (Spinal Morphine or Intravenous Lidocaine), compares the effectiveness of spinal analgesia to standard general anesthesia in improving patient recovery and overall surgical experience.

Table of Contents

Introduction

A clinical trial is being conducted to study the effects of intrathecal morphine in patients undergoing robot-assisted upper urologic surgery. This article aims to provide patients with a clear understanding of the treatment and its potential benefits.[1]

What is Intrathecal Morphine?

Intrathecal morphine is a form of pain medication that is injected directly into the fluid surrounding the spinal cord. The medication used in this study is an extract of fresh opium poppy, specifically prepared with ethanol. It is administered in small doses (up to 0.3 mg) to provide pain relief during and after surgery.[1]

Medical Conditions Treated

The study focuses on patients undergoing surgery for various urological conditions, including:

  • Renal or ureter malignancy: Cancerous growths in the kidney or ureter
  • Renal or ureter benign tumor: Non-cancerous growths in the kidney or ureter
  • Nephrolithiasis: Kidney stones
  • Renal reflux: A condition where urine flows backward from the bladder to the kidneys

These conditions may require robot-assisted laparoscopic surgery of the upper urinary tract.[1]

Study Objectives

The main goal of this study is to determine if adding spinal analgesia (pain relief) with bupivacaine and morphine to general anesthesia can improve recovery after robot-assisted laparoscopic upper urinary tract surgery. Researchers will measure this improvement using a patient-centered outcome scale called “Quality of Recovery 15” (QoR-15).[1]

Secondary objectives include investigating whether this approach results in:

  • Less pain
  • Faster mobilization (ability to move around)
  • Shorter hospital stays
  • Fewer complications
  • Effects on intraoperative (during surgery) blood pressure and heart function
  • Changes in inflammatory markers in the body

Eligibility Criteria

To participate in this study, patients must meet certain criteria:

Inclusion Criteria:

  • Scheduled for elective robot-assisted upper urinary tract surgery at a participating hospital
  • Able to provide informed consent after receiving information about the study

Exclusion Criteria:

  • ASA-class IV or above (a measure of overall health status)
  • Minors or those declared incompetent
  • Severe psychiatric disease
  • Inability to understand study information due to vision, hearing, or language barriers
  • Pregnancy or lactation
  • Emergency surgery
  • Contraindications to spinal analgesia (e.g., severe blood clotting disorders, severe aortic stenosis, previous back surgery with rods)
  • Contraindications to lidocaine infusion (e.g., allergy to local anesthetics, severe kidney or liver failure, severe heart problems)

These criteria ensure the safety of participants and the reliability of the study results.[1]

Potential Benefits

The use of intrathecal morphine in this study may offer several potential benefits for patients:

  • Improved overall recovery after surgery
  • Better pain management
  • Faster return to normal activities
  • Reduced need for other pain medications
  • Shorter hospital stays
  • Fewer postoperative complications

However, it’s important to note that these benefits are not guaranteed and are being studied as part of the clinical trial.[1]

Possible Side Effects

While intrathecal morphine can provide effective pain relief, it may also cause side effects. Some potential side effects being monitored in this study include:

  • Pruritus: Itching of the skin
  • Nausea and vomiting
  • Respiratory depression: Slowed breathing rate, which in severe cases may require treatment with a medication to reverse the effects of morphine
  • Changes in blood pressure during surgery

The study closely monitors patients for these and other potential side effects to ensure participant safety.[1]

Conclusion

This clinical trial aims to improve pain management and overall recovery for patients undergoing robot-assisted upper urologic surgery. By studying the effects of intrathecal morphine, researchers hope to enhance patient care and outcomes. If you’re considering participating in this study, discuss the potential benefits and risks with your healthcare provider to make an informed decision.[1]

Aspect Details
Trial Name SMILe: Spinal Morphine or Intravenous Lidocaine in robot-assisted upper urologic surgery
Main Objective To study the effect of spinal analgesia with bupivacaine and morphine on postoperative recovery
Medical Conditions Renal or ureter malignancy, benign tumors, nephrolithiasis, renal reflux
Primary Endpoint QoR-15 score at postoperative day 1
Key Secondary Endpoints Pain levels, time out of bed, length of stay, postoperative complications, opioid requirements
Drug Used Morphine (intrathecal administration)
Maximum Dose 0.3 mg (daily and total)
Trial Category Phase III

FAQ

  • What is the main objective of this clinical trial? The main objective is to study whether adding spinal analgesia with bupivacaine and morphine to general anesthesia improves recovery after robot-assisted laparoscopic upper urinary tract surgery. This improvement is measured using a patient-centered outcome scale called 'Quality of Recovery 15' (QoR-15).
  • What medical conditions are being studied in this trial? The trial focuses on patients with various upper urinary tract conditions, including renal or ureter malignancy, benign tumors, nephrolithiasis (kidney stones), and renal reflux.
  • Who is eligible to participate in this study? Eligible participants are patients scheduled for elective robot-assisted upper urinary tract surgery at one of the participating hospitals. They must provide informed consent after receiving information about the study. However, there are several exclusion criteria, such as being a minor, having severe psychiatric disease, or having contraindications to spinal analgesia.
  • What are some of the secondary outcomes being measured in this trial? Secondary outcomes include pain levels at various time points, time spent out of bed, length of hospital stay, postoperative complications, opioid requirements, and various intraoperative measurements such as blood pressure and cardiac function.
  • How is morphine used in this clinical trial? In this trial, morphine is used as part of the spinal analgesia. It is administered intrathecally (into the spinal fluid) along with bupivacaine. The maximum daily dose and total dose of morphine used in the trial is 0.3 mg.

Ongoing Clinical Trials on Extract Of Fresh Opium Poppy (1:2.2-2.7), Extraction Solvent: Ethanol 31.2 % (M/M)

  • Study on Spinal Morphine, Intravenous Lidocaine, and Bupivacaine for Patients Undergoing Robot-Assisted Surgery for Kidney or Ureter Conditions

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • Intrathecal: Refers to the space under the arachnoid membrane of the brain or spinal cord, where cerebrospinal fluid circulates. In this trial, it refers to the method of administering medication directly into the spinal fluid.
  • Robot-assisted laparoscopic surgery: A minimally invasive surgical technique that uses a robotic system to assist the surgeon in performing complex procedures through small incisions.
  • Spinal analgesia: A method of pain relief that involves injecting pain medication into the fluid surrounding the spinal cord.
  • QoR-15 (Quality of Recovery 15): A patient-reported outcome measure used to assess the quality of recovery after surgery.
  • Bupivacaine: A local anesthetic medication used to numb an area of the body during and after surgery.
  • Nephrolithiasis: The medical term for kidney stones, which are hard deposits of minerals and salts that form inside the kidneys.
  • Renal reflux: A condition where urine flows backward from the bladder into the kidneys, potentially causing kidney damage.
  • PACU (Post-Anesthesia Care Unit): A specialized unit in a hospital where patients are monitored immediately after surgery as they recover from anesthesia.
  • PONV: Post-Operative Nausea and Vomiting, a common side effect after surgery and anesthesia.
  • ASA class: American Society of Anesthesiologists physical status classification system, used to assess a patient's pre-anesthesia medical fitness.

References

  1. http://clinicaltrials.eu/trial/study-on-spinal-morphine-intravenous-lidocaine-and-bupivacaine-for-patients-undergoing-robot-assisted-surgery-for-kidney-or-ureter-conditions/