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Labor Pain clinical trials

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NCT ID: NCT02412969 Completed - Labor Pain Clinical Trials

Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Start date: August 2014
Phase: N/A
Study type: Interventional

This study is to examine the onset of pain relief with two different methods of labor epidural. The traditional labor epidural involves the placement of numbing and anti-pain medicine in the epidural space which surrounds the spinal cord. In order to take effect, the medication has to cross a layer of tissue called the dura. In the current study, the same medications are placed in the epidural space after the dura is punctured with a fine needle. This research, will help evaluate whether this technique will result in earlier onset of pain relief.

NCT ID: NCT02340806 Completed - Labor Pain Clinical Trials

Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses

Start date: January 2015
Phase: N/A
Study type: Interventional

Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.

NCT ID: NCT02327559 Completed - Labor Pain Clinical Trials

Prenatal Education About Reducing Labor Stress (PEARLS)

PEARLS
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.

NCT ID: NCT02274467 Completed - Labor Pain Clinical Trials

Response Patterns to the Electric Stimulation of Epidural Catheters in Term Pregnant Women

Start date: November 2014
Phase: N/A
Study type: Interventional

Lumbar epidural analgesia is commonly used for labor pain relief due to its effectiveness and safety. Despite its very high success rate, the epidural technique remains a rather blind technique and failures continue to occur. The correct placement of an epidural catheter, however, remains a clinical problem, since there is no imaging technique that could be used at the bedside to determine the exact positioning of the catheter. The technique of a trans-catheter electric stimulation test (TCEST) has been successfully used to detect the proper epidural catheter location for pediatric, post-operative and laboring obstetric patients. The response to the TCEST with the uniport (single hole) epidural catheters has been well described. There is a growing body of evidence that multiport epidural catheters provide an advantage to uniport catheters, since additional ports likely allow for an enhanced distribution of the local anesthetic solution. This was shown to result in a lower incidence of inadequate analgesia, including unilateral sensory blockade and missed sensory segments. The characteristics of the TCEST response using a multiport catheter remain to be determined. The aim of this study is to compare the response patterns to the TCEST using a single port versus multiport wire reinforced epidural catheters. The hypothesis of this study is that the incidence of a bilateral response to the TCEST will be higher in the multiport catheter as compared to the uniport catheter.

NCT ID: NCT02244086 Completed - Obstetric Pain Clinical Trials

Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor

EBWL
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Abstract. Epidural analgesia is the most safe and effective for the treatment of pain of childbirth method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most widely used local anesthetic in obstetric anesthesia. Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women in labor. Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure, heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at different periods of time. Results: Demographic characteristics and parity were compared, no statistically significant differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into statistically significant differences in favor of the group with 0.25% Bupivacaine with decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial pressure, heart rate and respiratory rate were found between the two groups. Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared with 0.125% bupivacaine.

NCT ID: NCT02185079 Completed - Labor Pain Clinical Trials

The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia

Start date: January 2014
Phase: N/A
Study type: Interventional

Procedural skills are an important determinant of clinical outcomes for certain patient groups. Training for procedural skills in the medical profession is still largely based on an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by "practicing" on patients under direct supervision by seniors (consultants or senior registrars/residents). Learning a complex and high risk procedural skill on patients is not ideal. As medical training moves from apprentice based to competency based training along and as for the number of clinical learning opportunities for trainees is less, it is necessary to develop a comprehensive training programme which enables effective and efficient learning without compromising on patient safety. Metrics-based performance based progression has shown to improve clinical performance not only in novices but also in experts. We envisage a standard methodology which could address the deficiencies in procedural training currently. This would entail development and validation of a set of metrics for a particular procedure, evaluation of a proficiency based progression training programme based on those metrics to and demonstration of improved clinical performance and clinical outcome associated with that programme. Although elements of this "end -end" approach have been demonstrated previously for various procedures, we propose to apply this methodology in its entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To date we have developed and are validating a set of metrics for this procedure. Proficiency based training leading to better procedural skills leading to better patient outcomes has not been studied so far. Epidural analgesia during labor lends itself as an excellent model for evaluating the whole process. It has a specific procedural skill which is closely linked to patient outcome which is measurable and occurs in finite time interval. The hypothesis of the study is that in novice anaesthetic trainees, training with metrics based performance based progression in addition to improving the clinical performance will also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved by conventional training.

NCT ID: NCT02179879 Completed - Labor Pain Clinical Trials

Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement

Start date: November 2013
Phase: N/A
Study type: Observational

Procedural skills play an important role in anaesthetic expertise. More focused training and assessment of procedural skills will be needed in the future as training moves from an apprenticeship based training system to competency based assessment. Currently various techniques exists to assess procedural skills of anaesthetist. For epidural catheter placement, task specific check list, global rating scales and cumulative sum techniques have been developed and validated. These techniques aim either for better qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in objectivity in turn hampers inter-rater reliability which is an essential component of a valid assessment model. Checklists type assessments force the developer to comprehensively characterize the procedure of interest and then validate the completed procedure characterization. This approach has been quantitatively shown to have higher assessment reliability levels compared to Likert-scale assessment. The objective of the project is to develop and validate a comprehensive procedure characterization for labor epidural catheter placement. Another objective is to compare this new assessment tool with existing checklist and global rating scale for labor epidural to establish concurrent validity.5 A well-developed objective, validated procedure characterization serves as a master tool which has multiple applications. It helps to build a training programme for the procedure, allows providing metrics based feedback to trainees using simulator, helps to assess the performance of trainees and in future might be used as benchmark to allow competency based progression in the training.

NCT ID: NCT02122705 Completed - Labor Pain Clinical Trials

A Case Series of VPIA Using Remifentanil for Labour and Delivery

VPIA
Start date: May 2012
Phase: N/A
Study type: Observational

This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.

NCT ID: NCT02105558 Completed - Pregnancy Clinical Trials

Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)

Start date: April 2014
Phase: Phase 4
Study type: Interventional

To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).

NCT ID: NCT02084589 Completed - Labor Pain Clinical Trials

A Comparison Study of Patient Controlled Epidural Analgesia (PCEA) With and Without Basal Infusion Using Ropivacaine 0,15% and Fentanyl μg/ml for Pain Relief in Labor, Assessment of Efficacy and Maternal Satisfaction.

Start date: June 2012
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double blind study, in which a comparison of patient controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being investigated. The purpose of the study is the assessment of the efficacy of labor analgesia and maternal satisfaction. Written informed consent is obtained by all parturients. Non invasive monitor of blood pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal heart rate is being placed. The participants are randomized in two groups, both receiving the same drug (ropivacaine 0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes. Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10 minutes. All parturients have to be instructed to self administration of epidural bolus dose when they experience mild to moderate pain. Both parturient and anesthetist who conducts the study and treat breakthrough pain, are blind to group assignment. After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary resuscitation are also recorded.