Clinical Trials

Clinical Trial – Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Approximately 500 patients will be included in this patient registry. Data collection
includes demographics, clinical data of underlying disease and use of bisphosphonates,
denosumab and antiangiogenic drugs , degree and extension of osteonecrosis,
osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

Clinical Trial – Pharmacokinetics of Levobupivacaine After Cesarean Section

Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard of
care for analgesia after cesarean section. There is no information on levobupivacaine
pharmacokinetics post TAP after pregnancy.

Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the
electrocardiogram (ECG).

Method: The investigators will study 12 healthy term pregnant patients, scheduled for
elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with 20
ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at 1-2-6
and 12 hours post puncture. 2 ml of venous blood will be obtained at 2-5-10-30-45-60-90 and
180 minutes. With a Holter machine we will study the effect of levobupivacaine plasma levels
and the QTc changes.

Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .

Clinical Trial – Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia
using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite
effective surgical anesthesia, bupivacaine is associated with long duration motor block and
dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its
new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and
faster regression of motor block compared to other local anesthetics without noteworthy
side-effects when used intrathecally. The aim of this randomized, multicenter, powered
clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric
bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid
rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers
shorter motor block and more rapid rehabilitation than bupivacaine.

Clinical Trial – Comparative Study of the Analgesic Effect of Spinal Anesthesia or Infiltration Anesthesia for Hemorrhoidectomy

Background and Objectives: Postoperative analgesia and early recovery are relevant for
hospital discharge after hemorrhoidectomy. This study investigated the postoperative
analgesic effect with local infiltration compared with spinal block.

Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG)
received local infiltration under general anaesthesia; spinal group (SG) received a
subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol
infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5%
hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1%
lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation,
motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse
effects.

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