10 Clinical Trials for Various Conditions
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.
This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups: * A seven-point Anesthesia Experience Survey * Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded * Amount of medications used during the sedation * Length of sedation
The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads and healthcare providers (HCPs) will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS) two-way communication between an HCP and patient, while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to: Primary aim: Quality of Clinical Care: Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery. Secondary aims: Quality of Clinical Care: 1. Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium. 2. Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks. 3. Determine if the use of WebTIPS reduces parental preoperative anxiety. Experience of Care: Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode. Cost of Care/Resource Use: Determine if WebTIPS modifies healthcare resource use, as measured by 30-day charges adjusted for Medicaid cost-to-charge ratios.
The purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the classic paravertebral bock.
Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative morbidity and mortality. This group of patients is at risk of perioperative desaturations which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA patients might also need to spend the night in intensive care for more frequent monitoring for any desaturations episodes especially if the patient will be requiring multiple intravenous narcotic boluses for pain control. Several studies have looked into the most appropriate way to manage these patients and some recommendations have been made to avoid outpatient surgery with close monitoring for first 24 hours after surgery specifically if patient will require intravenous postoperative narcotics. Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown. Nuvigil is longer acting product which is similar in action to Modafinil however is much cheaper. Nuvigil has not been previously studied for postoperative recovery. The investigators intend to study the effects of Nuvigil on postoperative recovery time and wakefulness in obstructive sleep apnea and obese patients.
Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance. Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration. Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.
The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. The aims of this study are to: PRIMARY AIM 1. Determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. The primary outcome will be observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale Preoperative Anxiety Scale). SECONDARY AIMS 1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ 2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires 3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
The purpose of this study is to determine whether the Halo Index has utility in detecting the difference between normal and non-normal recovery of patients in the first few hours immediately following major inpatient surgery. A small but significant percentage of patients who undergo major surgery will experience a major life-threatening complication in the first 30 days following surgery. The chance of developing one or more of these complications increases with the size of the surgery and with the severity of the patient's preexisting medical problems. It is unknown whether fluctuations in a patient's vital signs and other measures of bodily function that occur early in the recovery period are associated with postoperative complications. If this is so, it may be possible to predict who is at increased risk for complications based on monitoring during the early recovery period. This study will make use of the Halo Index, a compilation of measures of patient functions collected by non-invasive monitoring devices. In addition to heart rate, blood pressure, temperature, and breathing rate, these include measures of dissolved oxygen in the blood, the amount of hemoglobin in the blood, and other parameters. Patients will have two additional non-invasive monitors attached during their stay in the hospital post-anesthesia care unit (PACU). After the patient has been discharged from the hospital, their medical record will be reviewed at two time points: The first will be soon after discharge. Normal recovery patients will be defined as those who require only IV fluids, pain medications and anti-emetic medications. Non-normal recovery will include those who require transfusions of blood products, airway interventions such as a breathing tube, blood pressure medications, or heart rhythm medications. The second chart review will occur 30 days after surgery. In this review, the presence or absence of the following events will be ascertained: rapid response team calls, admission to the intensive care unit, infection, pneumonia, the need for transfusion of 5 or more units of blood within a three-day period, septic shock, the need for ventilation with a breathing tube, blood clot in the lung, kidney failure, coma, stroke, heart attack, and death.
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.
General anesthesia allows people to have surgery without experiencing the procedure or pain. To remain unconscious, the depth of sleep must be monitored. Various monitors have been developed, one of which is BIS (short for bispectral index). BIS monitors the level of sleep during anesthesia and improves patient recovery because the amount of sleep drugs can be fine-tuned to the individual. Patients who need a lot to stay asleep get more, and those who need less get less. As a result, patients tend to wake up faster with BIS monitoring as compared to standard practice not using BIS. Little is known about the long-term effects of BIS monitoring. This study investigates whether BIS monitoring during anesthesia improves long-term outcome, well after surgery is over. The hypothesis is that it does. Two groups of patients are compared: one in which BIS monitoring was used, and one in which it was not. Groups are compared on tests of memory, concentration and mental well-being, to see if one does and feels better than the other. The investigators also take blood samples to see how well patients' bodies deal with the surgery. The investigators expect the BIS monitoring group to do better.