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Labor Pain clinical trials

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NCT ID: NCT04124835 Completed - Labor Pain Clinical Trials

Effectiveness of Using the Swiss Ball in Birth

BIRTHBALL
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

A randomized clinical trial will be conducted to evaluate the effectiveness of using the Swiss Ball as a resource that reduces the length of labor time. The study will be conducted in the Low Risk Labor and Delivery sector of (Instituto Materno Infantil Professor Fernando Figueira) IMIP, which has a team of obstetric nurses, medical coordination and physical therapy support. The study population will be composed of low risk parturients admitted to the sector. Parturients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups: Group A (experimental) and Group B (control). Group A will be encouraged to use the Swiss Ball through pelvic movements, and Group B will go through the usual routine. Study results will be evaluated by assistants during labor and immediately after delivery.

NCT ID: NCT04109365 Recruiting - Anesthesia, Local Clinical Trials

Obstetric Placement Study Using EST

Start date: December 15, 2020
Phase: N/A
Study type: Interventional

Combined spinal-epidural (CSE) is an established technique for providing labour analgesia to obstetric patients which provides rapid onset but unsustained analgesia. The epidural catheter can be used to extend and provide continuous pain relief, however during single-segment needle-through-needle CSE, the catheter is untested. This study aims to confirm placement of epidural catheters of anesthesia through the epidural stimulation test (EST) which was first described by the PI of the study for confirming placement of epidural catheters approximately 20 years ago.

NCT ID: NCT04037085 Completed - Opioid Use Clinical Trials

Ketamine to Improve Recovery After Cesarean Delivery - Part 1

KINETIC
Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic modality to reduce pain and opioid requirements. In Part 1, physiochemical analysis of pharmacokinetic/pharmacodynamic (PK/PD) and breastmilk transfer of ketamine and its metabolites will be assessed. Additionally calculated estimations for neonatal and infant exposure will be assessed. In Part 2, PK/PD assessments will continue in a larger cohort; endpoints will also include postpartum pain, depression scores, central sensitization measures, patient-reported postpartum recovery scores, breastfeeding, and parent-infant bonding, assessed in the acute post-cesarean period and up to 12 weeks postpartum in a randomized controlled trial.

NCT ID: NCT04020042 Terminated - Labor Pain Clinical Trials

Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

Start date: August 28, 2019
Phase: N/A
Study type: Interventional

Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs). A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate the time for equipment setup due to its portability and instant power-up. In addition, it provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique features may be helpful in laboring women with a particular BMI range. We aim to define the usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in various BMIs. The primary outcome: The time needed to complete epidural placements. Secondary outcomes: - The number of needle insertion attempts, - The rate of success measured by the need to replacements during the labor course for vaginal or cesarean delivery.

NCT ID: NCT04011150 Recruiting - Labor Pain Clinical Trials

Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

VVAMB
Start date: August 11, 2020
Phase: Phase 3
Study type: Interventional

A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.

NCT ID: NCT04011098 Terminated - Labor Pain Clinical Trials

Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour

Start date: July 1, 2019
Phase: Phase 1
Study type: Interventional

Labour pain can be intensified for labour inductions and women undergoing inductions often have earlier and more frequent requests for analgesia. Current evidence suggests that epidural analgesia effectively manages pain in labour, but may give rise to adverse effects for both the mother and neonate. Opioids are often added to epidurals to improve the quality of analgesia. Despite reassuring findings regarding epidural opioids, other investigators have found an association between epidural opioids and neonatal respiratory distress, lower Neurological and Adaptive Capacity scores, and reduced rates of breastfeeding. Given the heightened implications for the mother and neonate in situations requiring induction of labour, the desire for a positive outcome whilst still providing adequate maternal analgesia is paramount. This study thus aims to investigate whether a preliminary epidural Fentanyl bolus at the initiation of the epidural may help to improve analgesia for women undergoing labour inductions for post-term pregnancy in a safe manner. Importantly, the main rationale of this proposed practice being that by achieving adequate epidural analgesia earlier in the labour induction, this may lead to better pain control overall and less overall requirements for epidural PCEA boluses and epidural "top-ups" as the induction progresses.

NCT ID: NCT03990441 Recruiting - Labor Pain Clinical Trials

Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor

Start date: February 11, 2019
Phase: N/A
Study type: Interventional

This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.

NCT ID: NCT03975816 Recruiting - Labor Pain Clinical Trials

The Application of Analgesia Nociception Index as an Objective Labor Pain Assessment During Epidural Analgesia

Start date: November 17, 2019
Phase:
Study type: Observational

Epidural analgesia is considered an effective and safe method for obstetric pain control. Currently, self-assessment pain scales remain to be the gold standard in labor pain evaluation after the administration of epidural analgesia. However, individual patient susceptibility to pain perception makes difficulties for the clinicians to assess the effectiveness of painless labor precisely. The aim of this study is to evaluate the validity of ANI in obstetric pain monitoring during epidural analgesia.

NCT ID: NCT03975660 Recruiting - Pain Clinical Trials

Evaluation of Objective Pain Measurement Device

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This study will attempt to objectively measure pain with an experimental device. The investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. A brain oxygenation device, Edwards Foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the CereVu ROPA device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.

NCT ID: NCT03940365 Completed - Labor Pain Clinical Trials

Fetal Life: Smart-Device Based Uterine Activity Monitoring

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

This study will compare the performance of a contraction monitor (tocometer) device developed by Fetal Life with standard tocometer devices. The study aims to test a uterine contraction monitor that can be applied by the patient to her abdomen and connected to her smart device to detect the frequency and duration of uterine contractions. Phase 1 will collect data for calibration of the monitor and for a noninferiority study comparing the Fetal Life uterine contraction monitor (tocometer) with standard tocometry devices. Phase 2 will be a feasibility study in which patients will position the monitor, connect to the corresponding Fetal Life app and measure their own uterine contraction activity. The study's hypothesis is that after calibration, the new monitor will reliably detect at least 95% of the number and duration of contractions detected by the standard monitor, and that the device will perform comparably whether applied by the patient or by research staff.