Intravenous Paracetamol in Adjunct to Intravenous Ketoprofen for Postoperative Pain in Children Undergoing General Surgery: A Double-Blinded Randomized Study.

Background and objectives: The combination of non-steroidal anti-inflammatory drugs and paracetamol is widely used for pediatric postoperative pain management, although the evidence of superiority of a combination over either drug alone is insufficient. We aimed to find out if intravenous (i.v.) paracetamol in a dose of 60 mg kg-1 24 h-¹, given in addition to i.v. ketoprofen (4.5 mg kg-1 24 h-¹), improves analgesia, physical recovery, and satisfaction with postoperative well-being in children and adolescents following moderate and major general surgery. Materials and Methods: Fifty-four patients were randomized to receive either i.v. paracetamol or normal saline as a placebo in adjunct to i.v. ketoprofen. For rescue analgesia in patients after moderate surgery, i.v. tramadol (2 mg kg-¹ up two doses in 24 h), and for children after major surgery, i.v. morphine-patient-controlled analgesia (PCA) were available. The main outcome measure was the amount of opioid consumed during the first 24 h after surgery. Pain level at 1 and over 24 h, time until the resumption of normal oral fluid intake, spontaneous urination after surgery, and satisfaction with postoperative well-being were also assessed. Results: Fifty-one patients (26 in the placebo group and 25 in the paracetamol group) were studied. There was no difference in required rescue tramadol doses (n = 11 in each group) or 24-h morphine consumption (mean difference (95% CI): 0.06 (⁻0.17; 0.29) or pain scores between placebo and paracetamol groups. In patients given morphine-PCA, time to normal fluid intake was faster in the paracetamol than the placebo subgroup: median difference (95% CI): 7.5 (1.3; 13.7) h, p = 0.02. Parental satisfaction score was higher in the paracetamol than the placebo group (mean difference: ⁻1.3 (⁻2.5; ⁻0.06), p = 0.04). Conclusions: There were no obvious benefits to opioid requirement or analgesia of adding regular intravenous paracetamol to intravenous ketoprofen in used doses. However, intravenous paracetamol may contribute to faster recovery of normal functions and higher satisfaction with postoperative well-being.

Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial.

BACKGROUND: There still is no evidence which neoadjuvant therapy regimen for stage II-III rectal cancer is superior. The aim of this study was to compare results achieved after long-course chemoradiotherapy (CRT) with short-term radiotherapy (RT) followed by delayed surgery. METHODS: A randomized trial was carried out between 2007-2013. One hundred fifty patients diagnosed with stage II-III rectal cancer were randomized into one of two neoadjuvant treatment arms: conventional chemoradiotherapy (CRT) and short-term radiotherapy (RT) followed by surgery after 6-8 weeks. Primary endpoints of this trial were downstaging and pathological complete response rate. Secondary endpoints were local recurrence rate and overall survival. RESULTS: The pathological complete response was found in 3 (4.4%) cases after RT and 8 (11.1%) after CRT (P = 0.112). Downstaging (stage 0 and I) was observed in 21 (30.9%) cases in RT group vs. 27 (37.5%) cases in CRT group (P = 0.409). Median follow-up time was 39.7 (range 4.9-79.7) months. 3-years overall survival (OS) was 78% in RT group vs. 82.4% in CRT group (P = 0.145), while disease-free survival (DFS) differed significantly - 59% in RT group vs. 75.1% in CRT group (P = 0,022). Hazard ratio of cancer progression for RT patients was 1.93 (95% CI: 1.08-3.43) compared to CRT patients. CONCLUSION: Three-years disease-free survival was better in CRT group comparing with RT group with no difference in overall survival. TRIAL REGISTRATION: http://clinicaltrials.gov identifier NCT00597311. January 2008.

Lithotomy versus jack-knife position on haemodynamic parameters assessed by impedance cardiography during anorectal surgery under low dose spinal anaesthesia: a randomized controlled trial.

BACKGROUND: Although the prone position providing better exposure for anorectal surgery is required it can cause a reduction of cardiac output and cardiac index. The goal was to compare haemodynamic changes assessed by impedance cardiography during anorectal surgery under low-dose spinal anaesthesia in lithotomy and jack-knife position. METHODS: The prospective randomized controlled study included 104, ASA I-II adult patients admitted for elective minor anorectal surgery, assigned to be performed in lithotomy (groupL, n = 52) or jack-knife position (groupJ, n = 52). After arrival to operating room the standard monitoring, impedance cardiography device was connected to the patient, and the following variables were recorded: cardiac output, cardiac index, systemic vascular resistance, stroke index at times of arrival to operating room, placement for, start and end of surgery and placement to bed. Spinal block was made in the sitting position with 4 mg of 0.5% hyperbaric bupivacaine and 10 µg of Fentanyl injected over 2 min. Comparison was based on haemodynamic changes between and inside groups over time. Student's t, chi square tests were used for statistical analysis with p < 0.05 regarded as statistically significant. RESULTS: The reduction of cardiac output was statistically significant after placement of the patient into the prone position: from baseline 7.4+/-1.6 to 4.9+/-1.2 after placement for and 4.7+/-1.2 at the start and end of surgery (mean +/-SD l/min). The difference of cardiac output between groups was 2.0 l/min after positioning for and the start of surgery and 1.5 l/min at the end of surgery (p < 0.05). Mean cardiac index reduced from baseline 3.9+/-0.8 to 2.6+/-0.7 and 2.4+/-0.6 (mean+/-SD l/min/m(2)) in groupJ and between groups: by 1.0 l/min/m(2) after placement for, 1.1 at the start and 0.8 at the end of surgery (p < 0.05). Systemic vascular resistance increased from baseline 1080+/-338 to 1483+/-479 after placement for, 1523+/-481 at the start and 1525+/-545 at the end of surgery in groupJ (mean+/-SD dynes/sec/cm(-5), p < 0.05). CONCLUSIONS: According to impedance cardiography, jack-knife position after low-dose spinal anaesthesia produces transitory, but statistically significant reduction of cardiac output and cardiac index with increase of systemic vascular resistance, compared to insignificant changes in lithotomy position. TRIAL REGISTRATION: Clinical Trials NCT02115178.

Association between use of enhanced recovery after surgery protocols and postoperative complications in colorectal surgery in Europe: The EuroPOWER international observational study.

STUDY OBJECTIVE: Assess the relationship between the Enhanced Recovery After Surgery (ERAS®) pathway and routine care and 30-day postoperative outcomes. DESIGN: Prospective cohort study. SETTING: European centers (185 hospitals) across 21 countries. PATIENTS: A total of 2841 adult patients undergoing elective colorectal surgery. Each hospital had a 1-month recruitment period between October 2019 and September 2020. INTERVENTIONS: Routine perioperative care. MEASUREMENTS: Twenty-four components of the ERAS pathway were assessed in all patients regardless of whether they were treated in a formal ERAS pathway. A multivariable and multilevel logistic regression model was used to adjust for baseline risk factors, ERAS elements and country-based differences. RESULTS: A total of 1835 patients (65%) received perioperative care at a self-declared ERAS center, 474 (16.7%) developed moderate-to-severe postoperative complications, and 63 patients died (2.2%). There was no difference in the primary outcome between patients who were or were not treated in self-declared ERAS centers (17.1% vs. 16%; OR 1.00; 95%CI, 0.79-1.27; P = 0.986). Hospital stay was shorter among patients treated in self-declared ERAS centers (6 [5-9] vs. 8 [6-10] days; OR 0.82; 95%CI, 0.78-0.87; P < 0.001). Median adherence to 24 ERAS elements was 57% [48%-65%]. Adherence to ERAS-pathway quartiles (≥65% vs. <48%) suggested that patients with the highest adherence rates experienced a lower risk of moderate-to-severe complications (15.9% vs. 17.8%; OR 0.71; 95%CI, 0.53-0.96; P = 0.027), lower risk of death (0.3% vs. 2.9%; OR 0.10; 95%CI, 0.02-0.42; P = 0.002) and shorter hospital stay (6 [4-8] vs. 7 [5-10] days; OR 0.74; 95%CI, 0.69-0.79; P < 0.001). CONCLUSIONS: Treatment in a self-declared ERAS center does not improve outcome after colorectal surgery. Increased adherence to the ERAS pathway is associated with a significant reduction in overall postoperative complications, lower risk of moderate-to-severe complications, shorter length of hospital stay and lower 30-day mortality.

Comparison of two continuous non-invasive haemodynamic monitoring techniques in the perioperative setting.

BACKGROUND: The aim of the study was to identify the accuracy of and agreement between two non-invasive haemodynamic monitoring techniques in the perioperative setting - thoracic electrical bioimpedance (TEB) and Edwards Lifesciences ClearSight system (CS). MATERIALS AND METHODS: The study included ten patients. Parametric quantitative data were expressed as mean ± SD. The Shapiro-Wilk test was used to test the normality of the distributions. A linear regression model was used to measure the strength of the linear relationship between TEB and CS. Bland-Altman analysis was performed to assess the mean difference, precision, and the limits of agreements (LOA). The Critchley and Critchley method was used to calculate the percentage error (PE), and if <30%, it was considered clinically acceptable. RESULTS: Ten patients were involved in our study. The mean cardiac output (CO) with TEB was 6.15 ± 1.14 L/min vs. 4.78 ± 1.40 L/min with CS (p < 0.01). The relationship was significant (n = 144; r 2 = 0.7; p < 0.01). The mean bias, LOA, and PE were 1.37 ± 1.01 L/min, 3.35 L/min and -0.61 L/min and 36.22%, respectively. The mean stroke volume index (SVI) with TEB was 48.64 ± 9.8 ml/beat/m2 vs. 37.12 ± 9.14 ml/beat/m2 with CS (p < 0.01). The relationship was significant (n = 144; r 2 = 0.65; p < 0.01). The mean bias, LOA, and PE were 11.52 ± 7.92 ml/beat/m2, 27.04 ml/beat/m2 and -4 ml/beat/m2 and 36.19%. CONCLUSIONS: The two methods of non-invasive haemodynamic monitoring are not compatible in the perioperative setting. However, the CS system has more advantages in terms of continuity and simplicity of monitoring, while measurements of TEB are interrupted by electrocautery.

Anaesthetic challenges in cancer patients: current therapies and pain management.

THE OBJECTIVE: The aim is to present the major effects of cancer treatment (chemotherapy, radiotherapy, surgery) that the anaesthesiologist should consider preoperatively, and to review techniques of the analgesic management of the disease. MATERIALS AND METHODS: To summarize the major challenges that cancer patients present for the anaesthesiologists, a literature review was conducted. Articles presenting evidence or reviewing the possible effects of anaesthetics on cancer cells were also included. Online databases of Science Direct, PubMed, and ELSEVIER, as well as reference lists of included studies were searched. Articles published from 2005 to 2016 were selected. RESULTS: Anaesthesiologists should pay attention to patients receiving chemotherapy and its side effects on organ systems. Bleomycin causes pulmonary damage, anthracyclines are cardiotoxic, and platinum-based chemotherapy agents are nephrotoxic. A lot of chemotherapy agents lead to abnormal liver function, vomiting, diarrhoea, etc. Surgery itself is suspected to be associated with an increased risk of metastasis and recurrence of cancer. Regional anaesthesia and general anaesthesia with propofol should be used and volatile agents should be avoided to prevent cancer patients from perioperative immunosuppression that leads to increased risk of cancer recurrence. Pain management for palliative patients remains a major problem. CONCLUSIONS: To provide the best treatment for cancer patients, cooperation of anaesthesiologists with oncologists and surgeons becomes imperative. It has been established that anaesthetic techniques and drugs could minimize the perioperative inflammation. However, further research of the perioperative "onco-anaesthetic" is needed.

[Minimal effective dose of spinal hyperbaric bupivacaine for adult anorectal surgery: a double-blind, randomized study]. / Spinalinio hiperbarinio bupivakaino minimali veiksminga doze darant anorektalines operacijas (dvigubai aklas atsitiktiniu imciu tyrimas).

UNLABELLED: The aim of the study was to find minimal effective dose of spinal hyperbaric bupivacaine for adult anorectal surgery. METHODS: The study included 93 adult consecutive patients admitted for anorectal operations. Dural puncture was made before surgery in the sitting position at L3-L4 or L4-L5 with 25-26G Tamanho spinal needle (BBraun, Germany) and different volumes of hyperbaric bupivacaine (Marcaine Spinal Heavy 0.5%, AstraZeneca) were injected over 2 minutes: group 1 (n=17) 1.5 ml, group 2 (n=38) 1.0 ml, group 3 (n=38) 0.8 ml. After sitting for 10 minutes patients were asked to lie down and surgery was started. Following variables were assessed: rate of success, level and duration of sensory and motor block, time to voiding and ambulation, complications, consumption of analgesics, quality of anesthesia according to the patient and medical staff. RESULTS: Groups were comparable in demographics. No case of failure was registered but 4 patients (10.5%) in the group 3 received supplemental i/v fentanyl to treat tension in the abdomen intraoperatively. Level of sensory block in groups 1, 2, 3 was 10.4+/-1.7, 7.013+/-2.2, 6.7+/-1.9 dermatomes, respectively (p<0.0001 ANOVA; p<0.0001 group 1 vs 2, group 1 vs 3, p=1.0 group 2 vs 3, Bonferroni). Extent of motor block was 2-3 scores according to the Bromage scale in 70.5% of group 1 cases, compared to 0-1 score in 97.3% of group 2 and 92.1% of group 3 cases. Median (range) duration of motor block in groups 1, 2, 3 was 90 (0-120), 0 (0-90), and 0 (0-60) min, respectively (p<0.0001 ANOVA; p<0.0001 group 1 vs 2, group 1 vs 3, p=0.13 group 2 vs 3, Bonferroni). Time of ambulation was 181.5+/-41.5, 136.6+/-32.2 and 123.0+/-45.9 min, respectively (p<0.0001 ANOVA; p<0.001 group 1 vs 2, p<0.00001 group 1 vs 3, p=0.43 group 2 vs 3, Bonferroni). There was no significant intergroup difference in time to urinate; retention developed in 20.4% of total cases. No difference was found in morphine consumption, 64.5% of cases did not require rescue analgesics. Quality of anesthesia was stated as excellent by the anesthesiologist and surgeon in all groups. However, quality was rated as excellent by patient in the operating room in groups 1, 2, 3: 58.8, 94.7, and 86.8%, respectively (p=0.003), on day 1 postoperatively: 76.5, 92.1, and 97.4%, respectively (p=0.023); by nursing staff: 82.4, 100, and 97.4%, respectively (p=0.019). Lower rates in group 1 were due to extensive motor block. In conclusion, a minimal recommended dose of spinal hyperbaric bupivacaine for anorectal surgery is 4-5 mg; a dose of 7.5 mg is excessive due to prolonged sensory and motor block.

Anesthesia for ambulatory anorectal surgery.

The prevalence of minor anorectal diseases is 4-5% of adult Western population. Operations are performed on ambulatory or 24-hour stay basis. Requirements for ambulatory anesthesia are: rapid onset and recovery, ability to provide quick adjustments during maintenance, lack of intraoperative and postoperative side effects, and cost-effectiveness. Anorectal surgery requires deep levels of anesthesia. The aim is achieved with 1) regional blocks alone or in combination with monitored anesthesia care or 2) deep general anesthesia, usually with muscle relaxants and tracheal intubation. Modern general anesthetics provide smooth, quickly adjustable anesthesia and are a good choice for ambulatory surgery. Popular regional methods are: spinal anesthesia, caudal blockade, posterior perineal blockade and local anesthesia. The trend in regional anesthesia is lowering the dose of local anesthetic, providing selective segmental block. Adjuvants potentiating analgesia are recommended. Postoperative period may be complicated by: 1) severe pain, 2) urinary retention due to common nerve supply, and 3) surgical bleeding. Complications may lead to hospital admission. In conclusion, novel general anesthetics are recommended for ambulatory anorectal surgery. Further studies to determine an optimal dose and method are needed in the group of regional anesthesia.

Low-dose spinal hyperbaric bupivacaine for adult anorectal surgery: a double-blinded, randomized, controlled study.

BACKGROUND AND OBJECTIVE: To produce selective spinal anesthesia for adult anorectal surgery. STUDY DESIGN: Double-blinded, randomized, controlled trial. SETTING: Operating room and postoperative recovery area. PATIENTS: 152 adult, consecutive ASA physical status I, II, and III patients. INTERVENTIONS: After patients underwent dural puncture in the sitting position at L3-L4 or L4-L5, 0.5% hyperbaric bupivacaine was injected over two minutes: Group S7.5 received 1.5 mL, Group S5 received 1.0 mL, and Group S4 0.8 mL. After sitting for 10 minutes, patients were positioned for surgery. MEASUREMENTS: Rate of success, level and duration of sensory and motor block, time to voiding and ambulation, complications, and quality of anesthesia according to the patient and medical staff, were recorded. RESULTS: Spinal block had a 98% rate of success. Mean level of sensory block was 10.4 +/- 1.7, 7.4 +/- 2.2, and 7.0 +/- 1.8 dermatomes in Groups S7.5, S5, and S4 (P < 0.01 S7.5 vs S5, and S7.5 vs S4). Mean duration of sensory block was 310.5 +/- 42.6, 255.9 +/- 43.7, and 228.8 +/- 34.8 min in Groups S7.5, S5, and S4 (P < 0.01 S7.5 vs S5, S7.5 vs S4, and S5 vs S4). Motor block was Bromage score 2-3 in 70.5% of Group S7.5 patients versus Bromage score 0-1 in 97.3% of Group S5 and 92.1% of Group S4 patients (P < 0.05). CONCLUSION: A dose of 4 mg of hyperbaric bupivacaine produces a similar level of sensory and motor block as a 5 mg dose but with shorter duration and faster recovery.