METHODS: A prospective observational study was undertaken at two tertiary care hospitals in Australia. Seventy-two (72) adults (mean age, 63±11 years) were included following cardiac surgery via a median sternotomy. Participants completed the Patient Identified Cardiac Pain using numeric and visual prompts (PICP), the McGill Pain Questionnaire-Short Form version 2 (MPQ-2) and the Medical Outcome Study 36-item version 2 (SF-36v2) Bodily Pain domain (BP), which were administered prior to hospital discharge, 4 weeks and 3 months postoperatively.
RESULTS: Participants experienced a high incidence of mild (n=45, 63%) to moderate (n=22, 31%) pain prior to discharge, which reduced at 4 weeks postoperatively: mild (n=28, 41%) and moderate (n=5, 7%) pain; at 3 months participants reported mild (n=14, 20%) and moderate (n=2, 3%) pain. The most frequent location of pain was the anterior chest wall, consistent with the location of the surgical incision and graft harvest. Most participants equated "pressure/weight" to "aching" or a "heaviness" in the chest region (based on descriptor of pain in the PICP) and the pain topography was persistent at 4 weeks and 3 months postoperatively. Each pain measurement tool provided different information on pain location, severity and description, with significant change (p<0.005) over time.
CONCLUSION: Mild-to-moderate pain was frequent after sternotomy, improved over time and was mostly located over the incision and mammary (internal thoracic) artery harvest site. Persistent pain at 3 months remained a significant problem in the community within this surgical population.
DESIGN: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included.
INTERVENTION: Participants were randomly allocated to one of two groups at 4 (SD 1) days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions). The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions) for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks.
OUTCOME MEASURES: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded.
RESULTS: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI -0.2 to 2.3) and 12 weeks (MD 0.4, 95% CI -0.9 to 1.6) postoperatively. There were no statistically significant between-group differences in secondary outcomes.
CONCLUSION: Modified (ie, less restrictive) sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with traditional or modified sternal precautions.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN12615000968572. [Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D (2018) Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. Journal of Physiotherapy 64: 97-106].
METHODS/DESIGN: This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported.
DISCUSSION: The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).
METHODS: Patients (n = 94) scheduled for gynaecological laparotomy received i.v. fentanyl infusion (3 μg/kg/h) after induction of general anaesthesia. Post-operative fentanyl requirements were quantified by using a patient-controlled analgesia and the number of i.v. fentanyl rescue analgesia required were recorded. Pain control was assessed using visual analogue scores (VAS) and fentanyl's adverse effects were documented. CYP3A4*4, CYP3A4*5 and CYP3A4*18 alleles of cytochrome P450 3A4 were identified by polymerase chain reaction-restriction fragment length polymorphism. Differences in fentanyl requirements, VAS scores and adverse effects among the various genotypes were compared.
RESULTS AND DISCUSSION: No CYP3A4*4 and CYP3A4*5 alleles were detected. Eighty-nine patients (94·7%) were wild-type, five (5·3%) were heterozygous and none was homozygous. No significant difference was demonstrated between the genotype groups in terms of fentanyl consumption, pain control and adverse effects.
WHAT IS NEW AND CONCLUSION: CYP3A4*4 and CYP3A4*5 are rare in the Malaysian Malay population. Genetic polymorphism of CYP3A4*18 may not play an important role in influencing postoperative fentanyl requirements.
OBJECTIVES: To assess the effects on mother and baby of a policy of selective episiotomy ('only if needed') compared with a policy of routine episiotomy ('part of routine management') for vaginal births.
SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (14 September 2016) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing selective versus routine use of episiotomy, irrespective of parity, setting or surgical type of episiotomy. We included trials where either unassisted or assisted vaginal births were intended. Quasi-RCTs, trials using a cross-over design or those published in abstract form only were not eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS: Two authors independently screened studies, extracted data, and assessed risk of bias. A third author mediated where there was no clear consensus. We observed good practice for data analysis and interpretation where trialists were review authors. We used fixed-effect models unless heterogeneity precluded this, expressed results as risk ratios (RR) and 95% confidence intervals (CI), and assessed the certainty of the evidence using GRADE.
MAIN RESULTS: This updated review includes 12 studies (6177 women), 11 in women in labour for whom a vaginal birth was intended, and one in women where an assisted birth was anticipated. Two were trials each with more than 1000 women (Argentina and the UK), and the rest were smaller (from Canada, Germany, Spain, Ireland, Malaysia, Pakistan, Columbia and Saudi Arabia). Eight trials included primiparous women only, and four trials were in both primiparous and multiparous women. For risk of bias, allocation was adequately concealed and reported in nine trials; sequence generation random and adequately reported in three trials; blinding of outcomes adequate and reported in one trial, blinding of participants and personnel reported in one trial.For women where an unassisted vaginal birth was anticipated, a policy of selective episiotomy may result in 30% fewer women experiencing severe perineal/vaginal trauma (RR 0.70, 95% CI 0.52 to 0.94; 5375 women; eight RCTs; low-certainty evidence). We do not know if there is a difference for blood loss at delivery (an average of 27 mL less with selective episiotomy, 95% CI from 75 mL less to 20 mL more; two trials, 336 women, very low-certainty evidence). Both selective and routine episiotomy have little or no effect on infants with Apgar score less than seven at five minutes (four trials, no events; 3908 women, moderate-certainty evidence); and there may be little or no difference in perineal infection (RR 0.90, 95% CI 0.45 to 1.82, three trials, 1467 participants, low-certainty evidence).For pain, we do not know if selective episiotomy compared with routine results in fewer women with moderate or severe perineal pain (measured on a visual analogue scale) at three days postpartum (RR 0.71, 95% CI 0.48 to 1.05, one trial, 165 participants, very low-certainty evidence). There is probably little or no difference for long-term (six months or more) dyspareunia (RR1.14, 95% CI 0.84 to 1.53, three trials, 1107 participants, moderate-certainty evidence); and there may be little or no difference for long-term (six months or more) urinary incontinence (average RR 0.98, 95% CI 0.67 to 1.44, three trials, 1107 participants, low-certainty evidence). One trial reported genital prolapse at three years postpartum. There was no clear difference between the two groups (RR 0.30, 95% CI 0.06 to 1.41; 365 women; one trial, low certainty evidence). Other outcomes relating to long-term effects were not reported (urinary fistula, rectal fistula, and faecal incontinence). Subgroup analyses by parity (primiparae versus multiparae) and by surgical method (midline versus mediolateral episiotomy) did not identify any modifying effects. Pain was not well assessed, and women's preferences were not reported.One trial examined selective episiotomy compared with routine episiotomy in women where an operative vaginal delivery was intended in 175 women, and did not show clear difference on severe perineal trauma between the restrictive and routine use of episiotomy, but the analysis was underpowered.
AUTHORS' CONCLUSIONS: In women where no instrumental delivery is intended, selective episiotomy policies result in fewer women with severe perineal/vaginal trauma. Other findings, both in the short or long term, provide no clear evidence that selective episiotomy policies results in harm to mother or baby.The review thus demonstrates that believing that routine episiotomy reduces perineal/vaginal trauma is not justified by current evidence. Further research in women where instrumental delivery is intended may help clarify if routine episiotomy is useful in this particular group. These trials should use better, standardised outcome assessment methods.
AIMS: This study was done to find out the most suitable anaesthesia for patients with fewer complications and also to look at the trend of anaesthesia being used.
METHODS: A retrospective analysis was done of patients who underwent cataract surgery from 2007 to 2014 in Hospital Melaka. Data were obtained from the National Eye Database and analysed using SPSS. Trend of types of anaesthesia used and the associated complications with each were studied.
RESULTS: The most frequently used anaesthesia was topical anaesthesia, which showed an upward trend followed by subtenon in turn showing a downward trend. Subtenon anaesthesia was associated with more intraoperative and postoperative complications while topical anaesthesia was associated with fewer complications.
CONCLUSIONS: Topical anaesthesia has shown a steady increase in usage and is the ideal anaesthesia, which has been associated with fewer complications.
METHODS: Patients fulfilling the International Headache Society (IHS) criteria for TN were prospectively interviewed for their demographic and clinical data. Pain intensity was rated with a visual analog scale (VAS), anxiety and depression were determined by the Hospital Anxiety and Depression Scale (HADS), and QoL was assessed by the Short-Form 36 (SF-36) questionnaire. Chi-square, Mann-Whitney U, and Spearman correlation tests were used to test for differences considering a significance level of P < .05.
RESULTS: Of the 75 included patients, 52 (69.3%) were women with a mean ± standard deviation (SD) onset age of 52.0 ± 12.7 years, and 57.3% were Chinese, 24.0% Malay, and 18.7% Indian. Pain was more common on the right side (69.3%) and in the maxillary and mandibular divisions. VAS scores for pain at its worst were higher in anxious/borderline anxious patients compared to non-anxious patients (89.5 ± 15.9 vs 80.9 ± 17.2, respectively; P < .05), and VAS scores for pain at its least were higher in depressed/borderline depressed subjects compared to non-depressed subjects (38.4 ± 25.8 vs 23.0 ± 19.2, respectively; P < .05). Chinese patients had lower VAS scores for pain at its least compared to Indian patients (19.7 ± 16.1 vs 39.9 ± 24.7; P < .01). TN patients scored lower in all eight domains of the SF-36 compared to the general population. Indian patients had lower scores in role limitations due to physical health (8.9 ± 23.2 vs 49.4 ± 43.8; P < .01) and social function (56.3 ± 13.6 vs 76.5 ± 23.6; P < .01) than Chinese patients, and Malay patients had lower mental health scores compared to Chinese patients (59.1 ± 19.5 vs 73.0 ± 21.0; P < .01).
CONCLUSION: Clinical characteristics of TN patients were similar to those of other populations. There were differences in pain ratings and QoL between TN patients of different ethnicities, as well as between those with anxiety and depression.