The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

BACKGROUND: Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. METHODS: The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score <7 at 1 minute. The secondary outcomes are an additional measure of pain relief, maternal sedation, nausea and vomiting, maternal oxygen saturation, satisfaction with analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. DISCUSSION: If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. TRIAL REGISTRATION: ISRCTN14898678Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant PB-PG-0407-13170_IR5.

Parametric model of human body shape and ligaments for patient-specific epidural simulation.

OBJECTIVE: This work is to build upon the concept of matching a person's weight, height and age to their overall body shape to create an adjustable three-dimensional model. A versatile and accurate predictor of body size and shape and ligament thickness is required to improve simulation for medical procedures. A model which is adjustable for any size, shape, body mass, age or height would provide ability to simulate procedures on patients of various body compositions. METHODS: Three methods are provided for estimating body circumferences and ligament thicknesses for each patient. The first method is using empirical relations from body shape and size. The second method is to load a dataset from a magnetic resonance imaging (MRI) scan or ultrasound scan containing accurate ligament measurements. The third method is a developed artificial neural network (ANN) which uses MRI dataset as a training set and improves accuracy using error back-propagation, which learns to increase accuracy as more patient data is added. The ANN is trained and tested with clinical data from 23,088 patients. RESULTS: The ANN can predict subscapular skinfold thickness within 3.54 mm, waist circumference 3.92 cm, thigh circumference 2.00 cm, arm circumference 1.21 cm, calf circumference 1.40 cm, triceps skinfold thickness 3.43 mm. Alternative regression analysis method gave overall slightly less accurate predictions for subscapular skinfold thickness within 3.75 mm, waist circumference 3.84 cm, thigh circumference 2.16 cm, arm circumference 1.34 cm, calf circumference 1.46 cm, triceps skinfold thickness 3.89 mm. These calculations are used to display a 3D graphics model of the patient's body shape using OpenGL and adjusted by 3D mesh deformations. CONCLUSIONS: A patient-specific epidural simulator is presented using the developed body shape model, able to simulate needle insertion procedures on a 3D model of any patient size and shape. The developed ANN gave the most accurate results for body shape, size and ligament thickness. The resulting simulator offers the experience of simulating needle insertions accurately whilst allowing for variation in patient body mass, height or age.

A national cross sectional survey of heads of midwifery services of uptake, benefits and barriers to use of obstetric early warning systems (EWS) by midwives.

OBJECTIVE: to identify the extent to which Early Warning Systems (EWS) are used by midwives in the United Kingdom (UK), the maternity settings they are used in, physiological parameters used to 'trigger' referral, training provision, barriers to implementation and role in preventing maternal morbidity. DESIGN: cross-sectional survey of heads of midwifery services. An email questionnaire was sent in September 2012. SETTING: UK NHS secondary care organisations providing maternity care. FINDINGS: heads of midwifery from 107 (68%) of 157 NHS organisations responded, with 108 questionnaires returned as two organisations had recently merged. All organisations, apart from one which only had a free-standing midwifery unit, had introduced EWS. Nearly all respondents (99%) reported EWS were used by midwives antenatally, 76% in labour and 100% on the postnatal ward. All EWS charts included body temperature, heart rate, respiratory rate, systolic blood pressure and oxygen saturation although parameters for escalation varied widely. Barriers to use of EWS by midwives included overlap with the partogram in labour, and staff shortages and delays obtaining clinical review when referral was triggered. Two-thirds considered EWS prevented maternal morbidity although few could provide supporting evidence, for example, audit findings. Training for midwives in use of EWS was available in 83% of organisations. CONCLUSION: most UK midwives are using EWS, with the highest use in obstetric units. The heterogeneity of EWS currently used potentially limits collation of evidence to inform appropriate system level responses. Research is needed to evaluate the role of EWS to prevent maternal morbidity during and after pregnancy in different maternity settings.

A review of epidural simulators: where are we today?

Thirty-one central neural blockade simulators have been implemented into clinical practice over the last thirty years either commercially or for research. This review aims to provide a detailed evaluation of why we need epidural and spinal simulators in the first instance and then draws comparisons between computer-based and manikin-based simulators. This review covers thirty-one simulators in total; sixteen of which are solely epidural simulators, nine are for epidural plus spinal or lumbar puncture simulation, and six, which are solely lumbar puncture simulators. All hardware and software components of simulators are discussed, including actuators, sensors, graphics, haptics, and virtual reality based simulators. The purpose of this comparative review is to identify the direction for future epidural simulation by outlining necessary improvements to create the ideal epidural simulator. The weaknesses of existing simulators are discussed and their strengths identified so that these can be carried forward. This review aims to provide a foundation for the future creation of advanced simulators to enhance the training of epiduralists, enabling them to comprehensively practice epidural insertion in vitro before training on patients and ultimately reducing the potential risk of harm.

Towards a realistic in vitro experience of epidural Tuohy needle insertion.

The amount of pressure exerted on the syringe and the depth of needle insertion are the two key factors for successfully carrying out epidural procedure. The force feedback from the syringe plunger is helpful in judging the loss of pressure, and the depth of the needle insertion is crucial in identifying when the needle is precisely placed in the epidural space. This article presents the development of two novel wireless devices to measure these parameters to precisely guide the needle placement in the epidural space. These techniques can be directly used on patients or implemented in a simulator for improving the safety of procedure. A pilot trial has been conducted to collect depth and pressure data with the devices on a porcine cadaver. These measurements are then combined to accurately configure a haptic device for creating a realistic in vitro experience of epidural needle insertion.