CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
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All Clinical Trials for bupivacaine hydrochloride; epinephrine
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00298571 ↗ | Cesarean Delivery and Post-operative Pain Management With Local Anesthesia | Completed | University of South Florida | Phase 2/Phase 3 | 2006-02-01 | The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain. |
NCT00458003 ↗ | Phenylephrine in Spinal Anesthesia in Preeclamptic Patients | Completed | Northwestern University | N/A | 2006-07-01 | Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH. |
NCT00519584 ↗ | Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone | Terminated | The Cleveland Clinic | N/A | 2007-07-01 | This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone. |
NCT00531349 ↗ | Regional Anesthesia and Endometrial Cancer Recurrence | Withdrawn | The Cleveland Clinic | Phase 3 | 2007-11-01 | The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia. |
NCT00636415 ↗ | Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis | Completed | Federal University of São Paulo | N/A | 2004-06-01 | CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis. DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University. METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined. |
NCT00813111 ↗ | Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation | Terminated | Pacira Pharmaceuticals, Inc | Phase 3 | 2008-11-01 | The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs. |
NCT00871442 ↗ | Parturient Controlled Epidural Analgesia (PCEA) With or Without a Basal Infusion for Early Labor | Withdrawn | Neil Roy Connelly, MD | Phase 3 | 2009-05-01 | Patient Controlled Epidural Analgesia is a widely used and effective means of adult pain management. However, Parturient Controlled Epidural Analgesia (PCEA) is a relatively new approach to pain control for the women in labor. With the recent acquisition of new PCEA technology at Baystate Medical Center it is now possible to make this patient controlled technology available on the Labor and Delivery unit. This study is designed to determine whether there is a difference in analgesia, side effects, or analgesic duration in patients who receive a bupivacaine and fentanyl PCEA for management of labor pain. The present study hypothesizes that an analgesic protocol that includes a basal infusion rate in addition to a bolus dose controlled by the patient will have a longer analgesic duration than a pump protocol that does not have a basal infusion added to a bolus dose controlled by the patient. Methods:The study population will consist of 100 adult obstetrical patients greater than 36 weeks gestation who request labor analgesia. Patients greater than 5 cm cervical dilation, patients who have received intravenous opioid agonists, or patients with a contraindication to fentanyl will be excluded. Patients with pre-eclampsia are also excluded. One of the following PCEA treatment protocols will be started in a randomized, double blind fashion.PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml Group 1: Basal Infusion: 0 ml/hr; Bolus 10 ml q 30min prn (10ml demand dose with 30min lockout) Group 2: Basal Infusion: 10 ml/h; Bolus 5 ml q 30min prn (5ml demand dose with 30min lockout) If the patient does not obtain relief within 30 minutes, the epidural catheter will be dosed with a local anesthetic and the study will be concluded. The patients without pain relief within 30 minutes are considered to have failed epidurals and are dropped from the study and the analysis. Following achievement of satisfactory analgesia, the patient will be evaluated every 30 minutes until they request additional analgesics. The study will "end" at this point, and the patient will be treated at the discretion of the anesthesiologist. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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