34 Clinical Trials for Various Conditions
The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.
This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.
This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.
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.
VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. The optimal strategy for pain management has not been defined. In this randomized, placebo-controlled, double-blinded clinical investigation, investigators hypothesize that 5 mcg/kg intrathecal morphine will decrease postoperative analgesic consumption and reduce pain.
This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
This is a randomized double blinded non-inferiority study comparing the duration of pain relief when patients receive one of three doses of spinal morphine. Enrolled patients will be randomly assigned to receive either 50 mcg, 150 mcg, or 250 mcg. All patients will receive standardized postoperative care, including multimodal analgesia. The primary outcome will be the time until the patient requests additional opioid pain medications.
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).
To determine whether the addition of erector spinae plane (ESP) catheters to existing multimodal analgesic regimen with intrathecal morphine provides superior postoperative analgesia in patients undergoing hepatic resection compared with patients not receiving ESP catheters.
the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.
This study may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Further, it may show whether there is any increased efficacy of adding truncal regional block or systemic lidocaine versus intrathecal opioid administration alone.
The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.
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.
This is a prospective, randomized, double-blinded, placebo-controlled study designed to examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and (2) a retrospective assay for endocannabinoids on previously collected specimens.
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted. None of the procedures or products used in this study are experimental. The length the study will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare pain and opioid side effects between people who get a drug pump and people who do not get a drug pump that will stay on their current pain medication treatment.
Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.
This is a randomized controlled study that will place patients into a "choice" and a "no choice" group. The choice group will be able to choose between receiving 100 mcg or 200 mcg intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200 mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3, 6, 12, 24, and 36 hours.
The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.
This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children. Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.
Patients undergoing posterior spinal fusion (PSF) procedures for scoliosis are at risk for iatrogenic neurologic injury of the spinal cord and/or spinal nerve roots during surgical correction of the abnormal spinal curvature. The degree of neurologic injury can range from minor sensory deficits to complete paraplegia. Surgeons at CHOP utilize neurophysiologists to identify impending neurologic injury. These consultants monitor spinal cord pathways by recording and analyzing evoked potentials during the operation. Evoked potentials are low voltage electrical signals generated in response to transcranial or transcutaneous electrical stimulation of motor and sensory neural pathways. Some patients undergoing PSF receive an injection of morphine into the cerebrospinal fluid during the operation. This intrathecal (IT) morphine has potent analgesic effects. While most commonly used anesthetic agents have well-characterized effects on evoked potentials, little data exists on the effects of IT morphine on transcranial electric motor-evoked potentials (TceMEPs). This is a prospective observational study to characterize the effects of IT morphine on TceMEPs.
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery. Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting. Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section. In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain. We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
• The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain control.