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NCT ID: NCT05184465 Completed - Anesthesia, Spinal Clinical Trials

Comparison of the Efficacy of 0.5% Bupivacaine, 0.5% Levobupivacaine, and 0.5% Hyperbaric Bupivacaine

BvsLBvsHB
Start date: December 18, 2017
Phase: N/A
Study type: Interventional

About 15 million spinal anesthesia procedures are performed worldwide each year. In the daily practice of the anesthesiologist for intrathecal use there are various local anesthetics such as bupivacaine, hyperbaric solution of bupivacaine, ropivacaine and levobupivacaine. From 1946 to 2017, only 16 studies comparing the clinical efficacy of isobaric and hyperbaric bupivacaine in nonpregnant patients have been conducted according to various databases. The small sample size and high heterogeneity of these results suggest that all results should be treated with caution. And, there is no conclusive evidence in favor of isobaric or hyperbaric bupivacaine regarding efficacy or side effects in the general surgical population. The literature describes such advantages of levobupivacaine as less cardiotoxicity, longer period of analgesia, more pronounced activity against sensory fibers than against motor fibers. In some studies it has been shown that levobupivacaine is equal to isobaric bupivacaine in efficacy. The efficacy of hyperbaric levobupivacaine equivalent to hyperbaric bupivacaine when administered intrathecally has also been shown on volunteers. However, in the literature there are different data on clinical efficacy of levobupivakin in comparison with ropivacaine and levobupivacaine. So during operations on extremities out of 20 patients surgical anesthesia developed in 18 patients. Fattorini F. et al. D in their study stated the same effectiveness of bupivacaine and levobupivacaine, but when using levobupivacaine in one patient general anesthesia was used due to insufficient spinal anesthesia. Other studies also reported similar efficacy of the two drugs, but surgical satisfaction with intraoperative anesthesia was 92.9% for bupivacaine and 83.9% for levobupivacaine for knee arthoroscopy. In their study, P Gautier et al. noted significantly lower efficacy of levobupivacaine in caesarean section compared to bupivacaine and ropivacaine for intrathecal use: 80% vs. 90% and 87%, respectively. According to Heng Sia et al. there is no clear evidence of the advantage of hyperbaric bupivacaine over isobaric bupivacaine for spinal anesthesia for cesarean section. The authors also noted that adequate randomized clinical trials with clear definitions, criteria and methodology for evaluating the transition to general anesthesia, requirements for additional analgesia, nausea, vomiting and sensory testing are needed. There is no clear practical guide to help anesthesiologists make informed decisions about the use of some form of intrathecal bupivacaine in non-cesarean surgery. Carefully designed, adequately conducted studies can provide further results that will contribute to sound clinical decision making. Given the above, the aim of the study is to compare the effectiveness of spinal anesthesia (SA) performed with 0.5% isobaric bupivacaine solution, 0.5% levobupivacaine solution and 0.5% hyperbaric bupivacaine solution in equivalent volumes in lower limb surgeries.

NCT ID: NCT05179876 Recruiting - Clinical trials for Hypertension, Pulmonary

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

PLATYPUS
Start date: May 4, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693 and NCT04565990]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

NCT ID: NCT05175612 Suspended - Clinical trials for Acute Respiratory Tract Infection

Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device

Start date: November 16, 2021
Phase:
Study type: Observational

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)

NCT ID: NCT05145894 Recruiting - Asthma Clinical Trials

Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Start date: September 30, 2021
Phase:
Study type: Observational

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.

NCT ID: NCT05122195 Recruiting - Quality of Life Clinical Trials

Graduated Elastic compRession for vAricose Veins in PrEgnancy

GRAPE
Start date: June 1, 2021
Phase:
Study type: Observational

This study will be evaluate the clinical efficacy of using graduated compression hosiery for venospecific symptoms, leg edema, and quality of life (QoL) in pregnant women with varicose veins (VV's).

NCT ID: NCT05108077 Not yet recruiting - Bladder Cancer Clinical Trials

Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells

Start date: March 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

NCT ID: NCT05054881 Completed - Nerve Block Clinical Trials

Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation

EPBwEPN
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only PEN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the sciatic nerve blockade by the subgluteal approach, performed only under ultrasound control without ESP, in comparison with the blockade of the sciatic nerve performed under ultrasound control with ESP, has not been established. Research hypothesis: the blockade of the sciatic nerve by the subgluteal approach performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.

NCT ID: NCT04895566 Completed - Clinical trials for Pyoderma Gangrenosum

Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma

Start date: May 24, 2021
Phase: Early Phase 1
Study type: Interventional

Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas. Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.

NCT ID: NCT04882007 Recruiting - Ulcerative Colitis Clinical Trials

Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

CoTikiS
Start date: October 2, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

NCT ID: NCT04878003 Recruiting - Clinical trials for Primary Myelofibrosis (PMF)

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.