Nocebo language in anaesthetic patient written information.

Recent evidence suggests that how anaesthesia information is presented may influence patient treatment outcomes. We conducted an observational study of anaesthetic-based patient information leaflets across NHS Trusts in England for their nocebo terms vs. therapeutic terms, and how adverse effects were presented. In this study, 'nocebo' is wording that may predispose the patient to expect adverse events such as pain or nausea. Data were extracted and analysed for word frequency, weighted proportion and thematic analysis. In total, 42 patient information leaflets from 61 NHS Trusts were analysed. 'Pain' was the second most common word across the leaflets, median (IQR [range]) 0.82 (0.50-1.0 [0.12-1.47]) per 100 words, second only to 'anaesthesia'. In comparison, 'safe' was the most common positively valanced word which featured eight times less frequently than 'pain' 0.10 (0.07-0.18 [0.0-0.84]) and 'comfort' featured 16.5 times less than 'pain' 0.02 (0.0-0.05 [0.0-0.13]). Multiple examples of phrasing that could have potential nocebo effects included, 'you will need strong painkillers' suggesting 'strong pain' and the need for 'painkillers' rather than using therapeutic terms focusing on 'comfort', 'healing' and 'recovery'. Our results suggest a dominance of phrases with negative content in the presentation of anaesthesia information provided to patients. Clinicians need to be aware of inadvertent generation of nocebo-weighted vs. comfort-weighted communication with patients. Our study findings suggest an opportunity for more emphasis to be placed on therapeutic outcomes and effective mitigation strategies of anaesthesia risks to avoid potential unintended nocebo effects of anaesthesia information leaflets or websites.

Implications of nocebo in anaesthesia care.

Nocebo refers to non-pharmacological adverse effects of an intervention. Well-intended procedural warnings frequently function as a nocebo. Both nocebo and placebo are integral to the generation of 'real' treatment effects and their associated 'real' side-effects. They are induced or exacerbated by: context; negative expectancy; and negative conditioning surrounding treatment. Since the late 1990s, the neuroscience literature has repeatedly demonstrated that the nocebo effect is mediated by discrete neurobiological mechanisms and specific physiological modulations. Although no single biological mechanism has been found to explain the nocebo effect, nocebo hyperalgesia is thought to initiate from the dorsal lateral prefrontal cortex subsequently triggering the brain's descending pain modulatory system and other pain regulation pathways. Functional magnetic resonance imaging shows that expectation of increased pain is accompanied by increased neural activity in the hippocampus and midcingulate cortex which is not observed when analgesia is expected. Functional magnetic resonance imaging studies have shown that the anterior cingulate cortex is pivotal in the perception of affective pain evoked by nocebo words. Research has also explored neurotransmitters which mediate the nocebo effect. The neuropeptide cholecystokinin appears to play a key role in the modulation of pain by nocebo. Hyperalgesia generated by nocebo also increases the activity of the hypothalamic-pituitary-adrenal axis as indicated by increases in plasma cortisol. The avoidance or mitigation of nocebo needs to be recognised as a core clinical skill in optimising anaesthesia care. Embracing the evidence around nocebo will allow for phrases such as 'bee sting' and 'sharp scratch' to be thought of as clumsy verbal relics of the past. Anaesthesia as a profession has always prided itself on practicing evidence-based medicine, yet for decades anaesthetists and other healthcare staff have communicated in ways counter to the evidence. The premise of every interaction should be 'primum non nocere' (first, do no harm). Whether the context is research or clinical anaesthesia practice, the nocebo can be ignored no longer.

Subcutaneous fentanyl for labour analgesia: a retrospective case note review.

BACKGROUND: In 2017, a South Australia Perinatal Practice Guideline was introduced state-wide for the use of subcutaneous fentanyl for labour analgesia as a replacement for intramuscular pethidine. We retrospectively reviewed the implementation of this practice change in our institution. METHODS: A retrospective review of maternal and neonatal case notes for the first 100 women administered subcutaneous fentanyl in labour at a single tertiary referral centre for maternity care, between February and June 2017. RESULTS: Of the 102 women administered subcutaneous fentanyl, the majority (55%) were primipara, with an average maternal age of 29 years and body mass index of 27 kg/m2. The median total fentanyl dose administered was 200 µg and the average time from last dose to birth was 3 h. The majority of women (70%) did not require additional rescue labour analgesia and 80% had a spontaneous vaginal birth. All neonates had a 5-min Apgar score >7. The median Apgar score at 1 and 5 min was 9. No neonate had an arterial cord blood pH <7.1. The mean arterial and venous cord blood pH was 7.3. The average time for neonates to establish breathing was 1 min and the median postnatal length of stay was two days. CONCLUSIONS: Subcutaneous fentanyl for labour analgesia appears effective and has a low incidence of adverse events.

Fentanyl concentration in maternal and umbilical cord plasma following intranasal or subcutaneous administration in labour.

BACKGROUND: The effect that the route of maternal fentanyl administration has on placental transfer of drug to the neonate is not well studied. Plasma concentration ratios are an indicator of fetal exposure, relative to the mother. METHODS: A cohort study (n=30) was conducted to measure fentanyl concentrations in maternal plasma, and arterial and venous cord blood, among women administered either intranasal or subcutaneous fentanyl for labour pain relief. Maternal and cord blood samples were collected within 30 min of birth to determine the fentanyl plasma concentration and to assess relative neonatal exposure. Neonatal outcomes were assessed by Apgar scores, need for resuscitation and nursery admission. RESULTS: Thirty paired samples were obtained from healthy parturients with uncomplicated term pregnancies. Highest observed umbilical venous and arterial concentrations were 0.71 ng/mL and 0.56 ng/mL, respectively, and fetal to maternal fentanyl plasma concentration ratios ranged between 0.23 and 0.73, indicating low fetal exposure. While the total intranasal fentanyl dose administered was significantly higher than the subcutaneous fentanyl dose, this did not result in a higher fetal to maternal ratio. All neonates in both groups had 5-min Apgar scores >7, two neonates required short-term stimulation and oxygen (unrelated to fentanyl) and no neonate was admitted to the nursery. CONCLUSION: This study is the first to examine fetal and maternal fentanyl concentrations after subcutaneous administration. This research supports the safe use of fentanyl for labour analgesia for women.

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

A survey of the sequelae of memorable anaesthetic drug errors from the anaesthetist's perspective.

Drug errors amongst anaesthetists are common. Although there has been previous work on the system factors involved with drug error, there has been little research on the sequelae of a drug error from the anaesthetist's perspective. To clarify this issue, we surveyed anaesthetists regarding their most memorable drug error to identify associated factors and personal sequelae regarding their professional practice after the event. An online survey was sent anonymously to 989 Australian and New Zealand College of Anaesthetists (ANZCA) Fellows in March 2016 and the results were collected over the following two months. There were 295 completed surveys (29.8% response). The majority of respondents were male consultants, aged over 45 years. Reported drug errors occurred most frequently during normal working hours, and the most common drugs involved were non-depolarising muscle relaxants. In 34% of the errors, another anaesthetist was present, and their presence was felt to have contributed in 40.7% of these cases. About 20% of respondents reported that they did not receive adequate support after the event. Sleep patterns were affected in 14.4% of respondents, although very few found that the error had affected their capacity to function at work. These findings suggest that memorable drug errors can be significant enough to have adverse sequelae to anaesthetists, even if no patient harm occurs.

Consent for labour epidural analgesia: an observational study in a single institution.

There is a wide range of practice amongst obstetric anaesthetists when obtaining consent for women requesting labour epidural analgesia. This is the first prospective observational study recording the number and types of risks mentioned and whether the risk was quantified. Statements of benefits and alternatives to the procedure were also noted. Fourteen anaesthetists, each consulting a single patient, were recorded during the process of obtaining consent and inserting the epidural. The most commonly mentioned risks (median 7) were headache/dural puncture, failure/difficulty with insertion, nerve damage, bleeding/haematoma and infection/epidural abscess. There was no difference between consultants and trainees, although consultants showed greater variance. It was uncommon for anaesthetists to state a benefit (21%) or mention an alternative option (21%), but there was usually a quantitative statement of risk (71%). Data showed a deviation from the Australian and New Zealand College of Anaesthetists guidelines and these findings may encourage anaesthetists to reflect on their own practice and guide future research.

A comparison of fentanyl with pethidine for pain relief during childbirth: a randomised controlled trial.

OBJECTIVE: To compare the efficacy of fentanyl administered via the subcutaneous (s.c.) or intranasal (i.n.) route with intramuscular (i.m.) pethidine in labouring women requesting analgesia. DESIGN: A randomised controlled trial three-armed, parallel-design. SETTING: A regional hospital and the largest tertiary maternity centre in South Australia. SAMPLE: One hundred and fifty-six healthy parturients birthing at term. METHODS: Women were randomised to receive s.c. fentanyl (n = 53), i.n. fentanyl (n = 52), or i.m. pethidine (n = 51). The outcomes were analysed by intention-to-treat. MAIN OUTCOME MEASURES: Pain scores measured before and 30 minutes after opioid administration. RESULTS: All groups reported clinically significant reductions in pain scores (mean range 1.2-1.6; P < 0.001), with no significant differences between groups. Significantly more women in the fentanyl groups reported satisfaction with using the study drug again, compared with women receiving i.m. pethidine (82.9% i.n. fentanyl, 80.6% s.c. fentanyl, and 44.0% i.m. pethidine; P < 0.01). Women in the fentanyl groups experienced less sedation (i.n. fentanyl 7.3%, s.c. fentanyl 2.9%, i.m. pethidine 44%; P ≤ 0.03), shorter labours by at least 2 hours (P < 0.05), and fewer difficulties establishing breastfeeding (78.8% i.m. pethidine, 39.4% i.n. fentanyl, and 44.0% s.c. fentanyl; P < 0.01). Neonates in the pethidine group were more likely to require nursery admission (P < 0.02). CONCLUSIONS: Fentanyl administered by s.c. and i.n. routes is as efficacious in relieving labour pain as i.m. pethidine, but resulted in greater satisfaction, less sedation, shorter labour, fewer nursery admissions, and fewer difficulties in establishing breastfeeding. Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women.

Time to get comfortable with a labour epidural.

Women frequently request regional analgesia during labour, yet little is known about how long it takes before they become comfortable. This prospective observational study aimed to determine various time-points following maternal request for regional analgesia in labour until comfort was achieved. It was conducted in two tertiary referral centres for maternity care in Australia between December 2009 and May 2010.Midwives and anaesthetists recorded times of maternal request for regional analgesia, anaesthetist contact,anaesthetist's arrival in the labour room, local anaesthetic infiltration on starting the procedure, injection of neuraxial local anaesthetic and first report of maternal comfort. Composite median times and interquartile range were recorded for maternal request to anaesthetist arrival, anaesthetist arrival to maternal comfort and total time from request to comfort. Statistical modelling and regression analyses assessed possible factors associated with these time intervals. A P value <0.05 was considered significant. Of the 324 maternal requests, 244 out of 324 (75.3%, 95% confidence interval 70.2% to 79.9%) were recorded as having achieved satisfactory labour analgesia. Median interquartile range times observed were: maternal request to anaesthetist arrival: 20 (10 to 35) minutes; anaesthetist arrival to maternal comfort: 40 (30 to 50) minutes; and total time from request to comfort: 65 (50 to 85) minutes. We have shown that approximately one hour is required for a mother to achieve comfort following her request for epidural analgesia during labour. Our findings are likely to provide useful information for antenatal education, enhance informed consent and improve the provision of anaesthetic services for labour analgesia.

Hypnosis antenatal training for childbirth: a randomised controlled trial.

OBJECTIVE: To determine the use of pharmacologic analgesia during childbirth when antenatal hypnosis is added to standard care. DESIGN: Randomised controlled clinical trial, conducted from December 2005 to December 2010. SETTING: The largest tertiary referral centre for maternity care in South Australia. POPULATION: A cohort of 448 women at >34 weeks of gestation, with a singleton pregnancy and cephalic presentation, planning a vaginal birth. Exclusions were: the need for an interpreter; pre-existing pain; psychiatric illness; younger than 18 years; and previous experience of hypnosis for childbirth. METHODS: All participants received usual care. The group of women termed Hypnosis + CD (hypnotherapist guided) were offered three antenatal live hypnosis sessions plus each session's corresponding audio CD for further practise, as well as a final fourth CD to listen to during labour. The group of women termed CD only (nurse administered) were played the same antenatal hypnosis CDs as group 1, but did not receive live hypnosis training. The control group participants were given no additional intervention or CDs. MAIN OUTCOME MEASURE: Use of pharmacological analgesia during labour and childbirth. RESULTS: No difference in the use of pharmacological analgesia during labour and childbirth was found comparing hypnosis + CD with control (81.2 versus 76.2%; relative risk, RR 1.07; 95% confidence interval, 95% CI 0.95-1.20), or comparing CD only with control (76.9 versus 76.2%, RR 1.01, 95% CI 0.89-1.15). CONCLUSIONS: Antenatal group hypnosis using the Hypnosis Antenatal Training for Childbirth (HATCh) intervention in late pregnancy does not reduce the use of pharmacological analgesia during labour and childbirth.

Chronic pain after caesarean delivery: an Australian cohort.

We investigated the incidence of and risk factors for persistent pain after caesarean delivery. Over a 12-month period, women having caesarean delivery were recruited prospectively at an Australian tertiary referral centre. Demographic, anaesthetic and surgical data were collected and at 24 hour follow-up, women were assessed for immediate postoperative pain and preoperative expectations of pain. Long-term telephone follow-up was conducted at two and 12 months postoperatively. Complete data were obtained from 426 of 469 women initially recruited (90.6%). The incidence of persistent pain at the abdominal wound at two months was 14.6% (n=62) but subsequently reduced to 4.2% (n=18) at 12 months. At two months, 33 patients (7.8%) experienced constant or daily pain. At 12 months, five patients (1.1%) continued to have constant or daily pain which was mild. There was no apparent increase in incidence of persistent pain associated with general versus regional anaesthesia (relative risk [RR] 0.89, 95% confidence interval [CI] 0.49 to 1.6); emergency vs elective procedure (RR 0.65, 95% CI 0.39 to 1.07); higher acute pain scores (RR 1.1, 95% CI 0.69 to 1.75); or history of previous caesarean delivery (RR 0.81, 95% CI 0.50 to 1.33). Persistent pain, usually of a mild nature, is reported by some women two months after their caesarean delivery, but by 12 months less than 1% of women had pain requiring analgesia or affecting mood or sleep. All declined a pain clinic review. Clinicians and patients can be reassured that caesarean delivery is unlikely to lead to severe persistent pain in the long-term.