Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- University of Virginia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Overall Benefits of Analgesic Score
Study Overview
Brief Summary
Moderate to severe postoperative pain is relatively common after major abdominal surgery. It is associated with less than optimal surgical experience, poor quality of recovery, and the development of persistent postsurgical pain. Opioids remain a significant component of postoperative pain management. Side effects of opioids used for the treatment of postoperative pain include constipation, pruritus, nausea, and vomiting. Enhanced recovery after surgery (ERAS) protocols involve the utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morph ne. IT morphine reduces the postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia. A significant number of patients who receive IT morphine still experience moderate to severe postoperative p in. Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications, thrombocytopenia, and/or coagulopathy.
Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients who underwent orthopedic, abdominal, complex spine, and cardiac surg ry. Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery. IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.
The hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry. It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving the quality of recovery after surgery.
Detailed Description
Moderate to severe postoperative pain is relatively common after major abdominal surgery. It is associated with less than optimal surgical experience, poor quality of recovery, and the development of persistent postsurgical pain. Opioids remain a significant component of postoperative pain management. Side effects of opioids used for the treatment of postoperative pain include constipation, pruritus, nausea, and vomiting. Enhanced recovery after surgery (ERAS) protocols involve the utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morph ne. IT morphine reduces the postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia. A significant number of patients who receive IT morphine still experience moderate to severe postoperative p in. Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications, thrombocytopenia, and/or coagulopathy.
Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients who underwent orthopedic, abdominal, complex spine, and cardiac surg ry. Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery. IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.
The hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry. It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving the quality of recovery after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- •Undergoing laparotomy with midline incision
- •Body mass index (BMI) between 18.5 and 45
- •Ability to understand and read English
- •Willingness and ability to comply with scheduled visits and study procedures
Exclusion Criteria
- •Not able or unwilling to sign consent
- •Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery
- •Patients with chronic pain, requiring daily opioid use at the time of surgery, MME >60 as the FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin.
- •Pregnant Women
- •Patients requiring emergent surgery
- •Contraindications to neuraxial anesthesia including:
- •Coagulopathy
- •localized infection at the site of injection
- •pre-existing spinal pathology, specifically defined as active radiculopathy, severe central canal stenosis in the lumbar region, or an acute fracture in the lumbar region
- •length of the QT interval (QTc) >450 on the most recent preoperative electrocardiogram (EKG)
- •Prior spinal fusion
- •Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone
Arms & Interventions
Intrathecal Morphine
250 mcg Intrathecal Injection prior to incision
Intervention: Morphine (Drug)
Intravenous Methadone
0.2 mg / kg Intravenous delivery prior to incision. Maximum dosage will be 20 mg.
Intervention: Methadone (Drug)
Outcomes
Primary Outcomes
Overall Benefits of Analgesic Score
Time Frame: 24 hours, 48 hours, 72 hours, 42 days, 92 days
The overall benefit of analgesic score (OBAS) is a daily survey that assesses a patient's satisfaction with analgesia, pain intensity, and adverse effects. To compute score, add all scores in items 1-7. Range: \[0 - 28\]. A low score indicates high benefit 1. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2. Grade any distress and bother from vomiting in the past 24 hours (0=not at all to 4=very much) 3. Grade any distress and bother from itching in the past 24 hours (0=not at all to 4=very much) 4. Grade any distress and bother from sweating in the past 24 hours (0=not at all to 4=very much) 5. Grade any distress and bother from freezing in the past 24 hours (0=not at all to 4=very much) 6. Grade any distress and bother from dizziness in the past 24 hours (0=not at all to 4=very much) 7. How satisfied are you with your pain treatment during the past 24 hours (0=not at all to 4= very much)
Quality of Recovery 15 score
Time Frame: 24 hours, 48 hours, 72 hours, 42 days, 92 days
The Quality of Recovery-15 (QoR-15) scale is a patient-reported outcome measurement of the quality of recovery after surgery and anesthesia. The scale ranges from 0 to 150, with a higher score indicating a better quality of recovery. A score of 0 indicates extremely poor quality of recovery, while a score of 150 indicates excellent quality of recovery. The QoR-15 score can be classified into four severity classes: excellent, good, moderate, and poor recovery.
Numeric Rating Scale pain scores (NRS)
Time Frame: 24 hours, 48 hours, 72 hours
The numeric rating scale (NRS) is a pain screening tool commonly used to assess pain severity at a given moment in time. It uses a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
morphine milligram equivalent
Time Frame: 24 hours, 48 hours, 72 hours
morphine milligram equivalent is a measurement of a given analgesic effect standardized to a milligram of morphine. In other words agent X has the same effect as Y milligrams of morphine.
Secondary Outcomes
- McGill Pain questionnaire score(42 days, 92 days)
- Numeric Rating Pain Score (NRS)(42 days, 92 days)
Investigators
Priyanka Singla
Assistant Professor of Anesthesiology
University of Virginia