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Epidural Analgesia clinical trials

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NCT ID: NCT05898737 Recruiting - Labor Pain Clinical Trials

Nociception Level Index (NOL Index) for Obstetrical Pain Assessment Under Epidural Analgesia.

Start date: June 20, 2023
Phase:
Study type: Observational

Pain has been defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Labour pain is the pain experienced during labour and childbirth and it's characterised by nociceptive pain accompanied by sympathetic activation. Since more than fifty years, the development of hospital obstetric assistance for labour, allowed the implementation of the pain relief culture in the demanding parturients population. The ideal labour analgesic technique should provide consistent pain relief at any stage of labour, have a long duration of action, while being safe both for the mother and the foetus. It should also anticipate undesirable side effects, such as motor block. The current gold standard for obstetric analgesia is the lumbar epidural technique using the administration of local anesthetics combined with opioids. However, the best administration mode is currently under debate, the main interest being the local anesthetic sparing responsible for various maternal side effects and the quality of maternal analgesia. Despite the intense research in the field, the evaluation of the labour pain remains difficult as performed by the midwife and the anesthesiologist based on the patient's behaviour and her subjective self-assessment. The PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel) is a non-invasive multiparametric nociception monitoring that has proved its interest in the intraoperative evaluation of patient's physiological response to pain under general anesthesia, using the NOL index variation. Nonetheless, it has been barely investigated in patients receiving locoregional anesthesia and never in the context of obstetrical pain. The investigators support the idea that the NOL index monitoring could allow us to assess the degree of nociceptive stimulation related to obstetric labour and its variation under epidural analgesia, as well as to compare the efficacy of sensitive block using different epidural administration modes. The aim of this pilot study is to evaluate the NOL Index variation during labour pain management with epidural analgesia. The investigators will focus on the evaluation of analgesia in relation with the self-reported pain intensity, and secondly, the characteristics of the sensory block, the hemodynamic variables and side effects.

NCT ID: NCT05812560 Recruiting - Epidural Analgesia Clinical Trials

Evaluation of a Protocol Posturalchanges in Women Giving Birth With Epidural Analgesia. Clinical Trial.

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

. The pain that occurs during labor is controlled in our environment through epidural analgesia. This mainly generates a sensory block but also a motor block that suppresses different reflexes physiological factors that facilitate the development of childbirth. Being necessary to adapt obstetric care to this reality. Among which are the changes postures of the immobile pregnant woman. General Objective: To evaluate the impact of a mobilization protocol during labor in pregnant women with epidural analgesia versus usual mobilization. Material and method Simple randomized clinical trial, in a 1:1 ratio. Population: nulliparous pregnant women and low-risk pregnancy, using epidural analgesia. Inclusion criteria: nulliparous pregnant women at term and low-risk pregnancy, in the active phase of labor and with epidural analgesia, voluntarily participating in the study. Sample size: Assuming an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided contrast, each group will contain 104 subjects to detect a difference 0.4 units. The intervention of the experimental group will consist of the application of a protocol of postural changes every 30-60 minutes or at least two postural changes in one hour during labor, in order to expand the diameters pelvics in the different phases of this. In the control group, each midwife will apply the postural changes according to her usual practice. Differences with the experimental group: the choice of postural changes according to the stage of labor, its cadence and the posture during the expulsive.

NCT ID: NCT05543824 Recruiting - Clinical trials for Anesthesia; Adverse Effect

Hemodynamic Impact of Epidural Anesthesia in Relation to Age in Pediatric Patients.

REHAEPP-2022
Start date: September 12, 2022
Phase:
Study type: Observational

Epidural analgesia is established as the gold standard in the management of post-surgical pain in multiple modalities, including the pediatric patient. It is a technique that is not without risks, but with multiple benefits such as less response to stress, less incidence of chronic pain after surgery, less incidence of nausea and vomiting and other adverse effects derived from opioids, faster recovery and increased patient and family satisfaction. However, as it has been mentioned, the epidural carries risks both in the technique itself (wet or intravascular puncture) and subsequently after the injection of medication that generates a sympathetic blockade with arterial hypotension and an increase in compensatory heart rate. Unlike in adult patients, in pediatric patients epidural and subarachnoid anesthesia are better tolerated hemodynamically due to less vagal and sympathetic activity and almost no systemic venodilation. This lower activity of the autonomic nervous system is due to its immaturity, which is why, with the growth of the infant, this anesthetic technique increasingly affects its hemodynamics, being similar to the adult at the age of 8-12 years. The study hypothesis does not differ from that stated in physiology books and studies, but the investigators seek to identify the direct correlation of age with the different hemodynamic parameters available with current technology (cardiac output, systemic vascular resistance, blood pressure ) in pediatric patients after epidural anesthesia. The study will be carried out in pediatric patients undergoing major surgery that requires the placement of an epidural catheter and invasive blood pressure, without modifying in any way the usual practice of the responsible anesthesiologist. The patient's hemodynamic data will be collected at time 0 (prior to catheter placement), one minute, 5 and 10 minutes after the bolus of local anesthetic administered to measure the child's hemodynamic response and relate it to their age and development. .

NCT ID: NCT05534945 Recruiting - Laparotomy Clinical Trials

PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose

PIBDOSE
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions. To address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication. Only a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision. However, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia. Hence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups. The primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day. Secondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.

NCT ID: NCT05323214 Recruiting - Epidural Analgesia Clinical Trials

Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Start date: August 1, 2021
Phase: Phase 4
Study type: Interventional

Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.

NCT ID: NCT04940091 Recruiting - Fever Clinical Trials

Epidural Analgesia and Maternal Fever During Labor

Start date: July 30, 2021
Phase:
Study type: Observational [Patient Registry]

Women who receive epidural analgesia during labor are more likely to develop fever than those who do not. Maternal fever during labor can produce various harmful effects on both mothers and infants. The investigators speculate that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.

NCT ID: NCT03161717 Recruiting - Epidural Analgesia Clinical Trials

Efficacy and Safety of Electrical Stimulation-guided Epidural Analgesia for Vaginal Delivery

Start date: March 11, 2015
Phase: N/A
Study type: Interventional

Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups will be defined based on the method used to identify the epidural space for epidural anesthesia: the loss of resistance group (n=20) and the epidural electrical stimulation group (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.