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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

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Clinical Trials for Bupivacaine Hydrochloride Preservative Free

Trial ID Title Status Sponsor Phase Summary
NCT00452972 Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery Completed Samuel Lunenfeld Research Institute, Mount Sinai Hospital N/A This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective CD under a strictly standardized spinal anesthetic. We hypothesized that in situ uterine repair would be more comfortable for the patients.
NCT00486902 Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients? Completed Northwestern University N/A Pain control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every organ system. There is growing evidence that ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant in postoperative pain control. A 2006 Cochrane Collaboration systemic review and meta-analysis concluded, "Ketamine in subanesthetic doses….is effective in reducing morphine requirements in the first 24 hours after surgery." Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses, is theorized to be due to blockade of spinal cord central sensitization. Central sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain perception over time despite no change in the intensity of the painful stimulus.Ketamine may also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements in women who received ketamine as part of a general anesthesia technique were decreased. Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and bupivacaine-fentanyl spinal anesthesia. In the United States, healthy women scheduled for elective cesarean delivery commonly receive spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not been studied as an adjuvant to this regimen in the analgesic management in post-cesarean delivery patients. Multimodal therapy for postoperative pain control is widely practiced due to the advantage it provides in blocking multiple pain pathways while minimizing side effects of each individual pain medication. We hypothesize that low dose intravenous ketamine will improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is to evaluate this hypothesis and study the possible side effects of this regimen in combination with bupivacaine-fentanyl-morphine spinal anesthesia.
NCT00635986 Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl Completed Federal University of São Paulo N/A CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries. DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo. METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.
NCT00845962 A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia Completed Centre hospitalier de l'Université de Montréal (CHUM) N/A The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT00845962 A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia Completed Université de Montréal N/A The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT01055236 Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients Completed Mahidol University Phase 4 Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01236859 Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus Completed Prince of Songkla University N/A Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after administration. Pruritus is the most common side effect of intrathecal morphine, which the incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of opioid-induced pruritus remain unclear and more than one mechanism may be involved in the development of opioid-induced pruritus, such as, mediated central µ opioid receptors, Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors, and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many medications have been used to treat this side effect included antihistamines, 5-HT3 (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol, and nonsteroidal antiinflammatory drugs. Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently approved by the Food and Drug Administration for the treatment of partial seizures and postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of unknown origin. However, there is only one small study in Taiwan shown the effectiveness of gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction). Because gabapentin has several side effects especially in high dose such as drowsiness, dry mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation, diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in orthopedic surgery in Songklanagarind Hospital.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Bupivacaine Hydrochloride Preservative Free

Condition Name

Condition Name for Bupivacaine Hydrochloride Preservative Free
Intervention Trials
Pain 5
Hypotension 3
Pregnancy 2
Nausea 2
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Condition MeSH

Condition MeSH for Bupivacaine Hydrochloride Preservative Free
Intervention Trials
Pain, Postoperative 7
Hypotension 4
Nausea 2
Pruritus 2
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Clinical Trial Locations for Bupivacaine Hydrochloride Preservative Free

Trials by Country

Trials by Country for Bupivacaine Hydrochloride Preservative Free
Location Trials
United States 26
Canada 5
Ireland 2
Thailand 2
Iran, Islamic Republic of 2
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Trials by US State

Trials by US State for Bupivacaine Hydrochloride Preservative Free
Location Trials
Pennsylvania 3
Alabama 2
Virginia 2
Illinois 2
Texas 2
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Clinical Trial Progress for Bupivacaine Hydrochloride Preservative Free

Clinical Trial Phase

Clinical Trial Phase for Bupivacaine Hydrochloride Preservative Free
Clinical Trial Phase Trials
Phase 4 17
Phase 2/Phase 3 3
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Bupivacaine Hydrochloride Preservative Free
Clinical Trial Phase Trials
Completed 12
Not yet recruiting 8
Recruiting 7
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Clinical Trial Sponsors for Bupivacaine Hydrochloride Preservative Free

Sponsor Name

Sponsor Name for Bupivacaine Hydrochloride Preservative Free
Sponsor Trials
University of Manitoba 3
Pacira Pharmaceuticals, Inc 3
Cork University Hospital 2
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Sponsor Type

Sponsor Type for Bupivacaine Hydrochloride Preservative Free
Sponsor Trials
Other 34
Industry 4
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