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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
40
University of Virginia
Charlottesville, Virginia, United States
RECRUITINGQuality of Recovery 15 score
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.
Time frame: 24 hours, 48 hours, 72 hours, 42 days, 92 days
Overall Benefits of Analgesic Score
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)
Time frame: 24 hours, 48 hours, 72 hours, 42 days, 92 days
morphine milligram equivalent
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.
Time frame: 24 hours, 48 hours, 72 hours
Numeric Rating Scale pain scores (NRS)
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."
Time frame: 24 hours, 48 hours, 72 hours
McGill Pain questionnaire score
The McGill Pain Questionnaire (MPQ), also known as the McGill Pain Index, is a self-report questionnaire that helps patients describe the quality and intensity of their pain that assesses three components of pain experience: Sensory intensity, Emotional impact, and Cognitive evaluation of pain. The MPQ consists of 20 categories of verbal descriptors, 78 pain-related descriptors, and six words for current pain intensity. The descriptors fall into four major groups: Sensory: 1 to 10 Affective: 11 to 15 Evaluative: 16 Miscellaneous: 17 to 20 Each descriptor has a rank value based on its position in the word set. The sum of the rank values is the pain rating index (PRI). The maximum pain score is 78, and the higher the score, the greater the pain. The MPQ is valid, reliable, and sensitive for measuring cancer pain.
Time frame: 42 days, 92 days
Numeric Rating Pain Score (NRS)
The numeric rating scale (NRS) is a pain screening tool commonly used to assess pain severity at a given moment. It uses a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Time frame: 42 days, 92 days
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