Outcomes and outcome measures utilised in randomised controlled trials of postoperative caesarean delivery pain: a scoping review.

BACKGROUND: Inadequately treated postoperative pain following caesarean delivery can delay recovery and the ability to care for a newborn. Effectiveness studies of interventions to treat postoperative caesarean delivery pain measure different outcomes, limiting data pooling for meta-analysis. We performed a comprehensive review of existing outcomes with the aim of recommending core outcomes for future research. METHODS: A scoping review to identify all outcomes reported in randomised controlled trials (RCTs) and clinical trial registries of interventions to treat or prevent postoperative caesarean delivery pain, with postoperative pain as a primary outcome measure. We searched PubMed, Web of Science, CINAHL, LILACS, Embase, CDSR and CRCT for studies from May 2016 to 2021. Outcomes were extracted and frequencies tabulated. RESULTS: Ninety RCTs and 11 trial registries were included. In total, 392 outcomes (375 inpatient and 17 outpatient) were identified and categorised. The most reported outcome domain was analgesia (n = 242/375, 64.5%), reported in 96% of inpatient studies, with analgesic consumption accounting for 108/375, 28.8% of analgesia outcomes. The second most common domain was pain intensity (n = 120/375, 32%), reported in 97% of inpatient studies, using the visual analogue scale (68/120, 59%) and the numerical reporting scale (37/120, 25%). Maternal and neonatal adverse effects accounted for 65/375 (17.3%) and 19/375 (5.1%) of inpatient outcomes, respectively. CONCLUSIONS: Outcomes reported in RCTs for postoperative caesarean delivery pain vary widely. The results of this review suggest that standardisation is needed to promote research efficiency and aid future meta-analyses to identify optimal postoperative caesarean delivery pain management.

Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery.

BACKGROUND: Few robust scoring tools exist to assess recovery following caesarean delivery (CD). We evaluated a new obstetric quality of recovery score (ObsQoR-11, initially formulated for elective CD) following non-elective CD. METHODS: ObsQoR-11 questionnaires were completed by women at day one post non-elective CD. Convergent validity was assessed by correlation of ObsQoR-11 with a 100 mm numerical rating scale (NRS) of general health status; discriminant validity by correlation with good vs poor recovery (NRS of ≥70 vs <70 mm, respectively); and content validity by correlation with length of stay (LOS), CD category, parity, gestation, previous CD, duration, blood loss, haemoglobin, age and body mass index. Cronbach's alpha, inter-item, split-half and test-retest correlation assessed reliability. Feasibility was tested by recruitment rate and time for ObsQoR-11 completion. RESULTS: One hundred women completed ObsQoR-11 at 24 h and 20 women repeated it at 25 h. ObsQoR-11 correlated strongly with NRS (r = 0.72 [95% CI 0.61 to 0.81], P <0.0001); discriminated well between good versus poor recovery (median [IQR] score 97 [86.5-101] vs 64 [50.5-78.5], P <0.0001); correlated to LOS (r = -0.24 [-0.42 to -0.04], P=0.02) and parity (r = 0.24 [0.04 to 0.42], P=0.02). Reliability was acceptable: Cronbach's alpha 0.75; inter-item correlation >0.15; split-half reliability 0.96; and intra-class correlation >0.6; no floor or ceiling effects. One hundred percent completed the ObsQoR-11 (median [IQR] completion time 117 [89-156] s). CONCLUSIONS: ObsQoR-11 is valid and reliable in assessing recovery after non-elective CD. Further research should assess generalisability and use following vaginal delivery.

Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery.

BACKGROUND: Whilst validated quality-of-recovery (QoR) tools exist for general surgery, there is no specific obstetric equivalent. We aimed to develop and evaluate a modified QoR score after elective Caesarean delivery. METHODS: Twenty-two obstetric specific items were selected following review and modification of the QoR-40 survey by 16 experts and interviews with 50 stakeholders. Item selection was based on relevance to Caesarean delivery and endorsement by >66% of stakeholders. Items were tested on women pre-delivery, at 24 h, and 25 h post-delivery. An 11-item obstetric-specific QoR score (ObsQoR-11) was created based on correlation with a numerical rating scale (NRS) of global health status (r>0.20) at all time points. Reliability, responsiveness, acceptability, and feasibility were tested. RESULTS: One hundred and fifty-two women responded to the 22-item questionnaire pre-delivery (complete in 146), 100 at 24 h, and 10 at 25 h. The ObsQoR-11 correlated with the global health status NRS (r=0.53; 95% confidence interval: 0.43-0.62; P<0.0001) and discriminated good vs poor recovery (NRS score ≥70 vs <70 mm) at 24 h. There was a negative correlation between the ObsQoR-11 score at 24 h and hospital length of stay (r=-0.39; P=0.003). ObsQoR-11 was reliable (internal consistency: 0.85; split-half 0.76; test-retest intra-class correlation coefficient ri>0.6 in 82% of items) and responsive (Cohen effect size: 1.36; standardised response mean: 0.85). A longer 22-item ObsQoR had high (97%) completion rates and short (median: 2 min) completion times. CONCLUSIONS: The ObsQoR-11 provides a valid, reliable, and responsive global assessment of recovery after elective Caesarean delivery.

Operating room-to-incision interval and neonatal outcome in emergency caesarean section: a retrospective 5-year cohort study.

We conducted a 5-year retrospective cohort study on women undergoing caesarean section to investigate factors influencing the operating room-to-incision interval. Time-to-event analysis was performed for category-1 caesarean section using a Cox proportional hazards regression model. Covariates included: anaesthetic technique; body mass index; age; parity; time of delivery; and gestational age. Binary logistic regression was performed for 5-min Apgar score ≥ 7. There were 677 women who underwent category-1 caesarean section and who met the entry criteria. Unadjusted median (IQR [range]) operating room-to-incision intervals were: epidural top-up 11 (7-17 [0-87]) min; general anaesthesia 6 (4-11 [0-69]) min; spinal 13 (10-20 [0-83]) min; and combined spinal-epidural 24 (13-35 [0-75]) min. Cox regression showed general anaesthesia to be the most rapid method with a hazard ratio (95%CI) of 1.97 (1.60-2.44; p < 0.0001), followed by epidural top-up (reference group), spinal anaesthesia 0.79 (0.65-0.96; p = 0.02) and combined spinal-epidural 0.48 (0.35-0.67; p < 0.0001). Underweight and overweight body mass indexes were associated with longer operating room-to-incision intervals. General anaesthesia was associated with fewer 5-min Apgar scores ≥ 7 with an odds ratio (95%CI) of 0.28 (0.11-0.68; p < 0.01). There was no difference in neonatal outcomes between the first and fifth quintiles for operating room-to-incision intervals. General anaesthesia is associated with the most rapid operating room-to-incision interval for category-1 caesarean section, but is also associated with worse short term neonatal outcomes. Longer operating room-to-incision intervals were not associated with worse neonatal outcomes.

Differential effects of sevoflurane on the metastatic potential and chemosensitivity of non-small-cell lung adenocarcinoma and renal cell carcinoma in vitro.

BACKGROUND: Increasing evidence suggests that perioperative factors including anaesthetics influence cancer recurrence and metastasis after surgery. This study investigated the influence of sevoflurane on the response of lung and renal cancer cells to cisplatin, with focus on transforming growth factor-beta (TGF-ß) and osteopontin (OPN) that are both closely associated with cancer tumorigenesis and metastasis. METHODS: Non-small cell lung adenocarcinoma (A549) and renal cell carcinoma (RCC4) cells were exposed to 3.6% sevoflurane for two hrs. Malignant potential represented by cell viability, migration, chemosensitivity to cisplatin was evaluated. Expression of OPN, TGF-ß1, TGF-ß receptor type II (TGF-ßRII) and the canonical downstream effector Smad3 was assessed. SiRNA knockdown of TGF-ß1 and OPN and chemical inhibition of TGF-ßRI/II was performed. RESULTS: Sevoflurane reduced cell viability (0.394) versus control (0.459) (P < 0.01), enhanced chemosensitivity but had no effect on migration of A549 cells. It enhanced viability (0.467) versus control (0.347) (P < 0.001), chemoresistance and migration of RCC4. In A549, there was enhanced nuclear Smad3. In RCC4, TGF-ßRII and OPN were upregulated, while TGF-ß1 was over- expressed with reduced nuclear Smad3. TGF-ßRII inhibition and OPN knockdown abolished sevoflurane-mediated viability, and migration, respectively, in RCC4. CONCLUSIONS: Sevoflurane promotes the metastatic potential of renal carcinoma, but not of non-small cell lung cancer. This may be associated with its differential effect on cellular signalling including TGF-ß. Our findings indicate that sevoflurane may have different effects on the metastatic potential and chemosensitivity of different tumour types.

Intravenous lipid emulsion - rescued at LAST.

The accidental overdose of local anaesthetics may prove fatal. The commonly used amide local anaesthetics have varying adverse effects on the myocardium and beyond a certain dose all are capable of causing death. Local anaesthetics are the most frequently used drugs in dentistry and although uncommon, local anaesthetic systemic toxicity (LAST) accounts for a high proportion of mortalities in the dental office, with local anaesthetic-induced cardiac arrest particularly resistant to standard resuscitation methods. Over the last decade there has been convincing evidence of using intravenous lipid emulsions as a rescue in local anaesthetic - cardiotoxicity and anaesthetic organisations over the globe have developed guidelines on the use of this drug. Despite this, however, awareness among practitioners appears to be lacking. All who use local anaesthetics in their practice should have an appreciation of patients at high risk of toxicity, early symptoms and signs of toxicity, preventative measures when using these drugs and the initial management of systemic toxicity with intravenous lipid emulsion. In this review we intend to discuss the pharmacology and pathophysiology of local anaesthetic toxicity, and the rationale for intravenous lipid emulsion therapy.