Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour-a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756).

BACKGROUND: Cardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is a second-line test of the acid-base status of the fetus. It is used to provide either reassurance that it is safe for labour to continue or objective evidence of compromise so that delivery can be expedited. Digital fetal scalp stimulation (dFSS) to elicit a fetal heart rate acceleration is an alternative less invasive second-line test of fetal wellbeing. This study aims to provide robust evidence on the role of these two second-line tests in assessing fetal wellbeing and potentially preventing operative delivery. METHODS: A multi-centre parallel group randomised controlled trial (RCT) is planned in four maternity centres in Ireland. The study aims to recruit 2500 nulliparous women with a term (≥37+0 weeks) singleton pregnancy who require a second-line test of fetal wellbeing in labour due to an abnormal CTG. Women will be allocated randomly to dFSS or FBS on a 1:1 ratio. The primary outcome is caesarean section. With 1250 women in each arm, the study will have 90% power to detect a difference of 5-6%, at a two-sided alpha significance level of 5%, assuming a caesarean section rate of at least 20% in the dFSS group. DISCUSSION: If the proposed study shows evidence that dFSS is a safe, reliable and effective alternative to FBS, this would have ground-breaking implications for labour management worldwide. It could potentially lead to a reduction in invasive procedures and emergency caesarean sections. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306756. Registered on 31 March 2022. The trial commenced enrolment on 10 May 2022. Ethical committee approval has been granted by the Research Ethics Committee (REC) of each hospital: Dublin/CWIUH REC: 12.06.2019; Cork/UCC REC: 29.11.2019; Galway/NUIG REC: 06.09.2019; Limerick/UL REC: 30.09.2019.

Surgeon-administered ilio-inguinal and pudendal nerve blocks for major vulval surgery: An observational study with visual analogue pain scoring.

Surgical excision of the groin and vulva is a painful procedure. Traditionally following general or regional anaesthesia, local anaesthetic was infiltrated around the wound. Thedistribution varied and the somatic pain control was not reliable. Inspired by the success of the application of peripheral nerve blocks for postoperative pain control with open abdominal procedures, we introduced blockade of the ilioinguinal nerve (IIN) and pudendal nerve (PN) into our vulval surgery to assess the requirement for parenteral and oral analgesia in the postoperative period. This is an observational study of all patients undergoing major vulval and/or related groin surgery. Sampling biopsies were excluded. Levobipuvicaine 0.25% (2.5 mg/ml) or 0.5% (5 mg/ml) was used for and dosage was calculated based on the patient's weight with no more than 2 mg/kg. For example, using 0.25% of levobupivacaine (2.5 mg/ml) for a 70 kg patient, 56 ml is administered divided into 4, giving 14mls at each site (2 sites abdominally for IIN block and 2 sites for pudendal block). Eighteen women were included in the analysis. Median age was 67 (range 34-81) years and thirteen (72%) were >60 years. Visual analogue scores (VAS) ranged from 0 to 3 for seventeen patients from day 0 to day 1 and fifteen patients from day 2 to day 5. Two patients had pain scores >4 on one or more postoperative days: one had chronic arthralgia and one had received a lower volume of bupivacaine. This observational study demonstrates that ilioinguinal and pudendal nerve LA blocks may be a valuable addition to the multimodal postoperative analgesic pathway for women undergoing major surgical excision in the vulva and groin.