Chronic pain after bilateral thoracotomy in lung transplant patients.

Background and aims The relative contribution of patient-related factors and intraoperative nerve damage for the development of chronic pain after surgery is unclear. This study aimed to examine chronic pain after bilateral thoracotomy. We hypothesized, that individual patient-related risk factors would be important resulting in an intraindividual uniformity of pain and hyperphenomena between the two sides of the thorax. Methods Twenty patients who had undergone lung transplantation via bilateral thoracotomy 6-12 months previously were included from the Danish Lung Transplant program, Rigshospitalet, Denmark, from October 2016 to August 2017. All patients answered questionnaires about pain in and around the scar, completed the Neuropathic Pain Symptom Inventory, and underwent bedside examination for hyperphenomena (brush- and cold-evoked allodynia, pinprick hyperalgesia) and pinprick hypoalgesia. Results Nine patients reported spontaneous pain bilaterally, five patients had pain on one side only, and six patients had no pain. Hyperphenomena were present on both sides of the thorax in 13 patients, on one side in four patients, and three patients had no hyperphenomena. The intraindividual uniformity of pain (p=0.029) and hyperphenomena (p=0.011) between the two sides of the thorax suggests that patient-related factors play an important role in the development of chronic pain. Conclusions The results of the present study provide support for the hypothesis of an individual predisposition for the development of chronic pain after thoracotomy. Implications Patient-related risk factors contribute to the development of chronic pain after thoracotomy. This result most likely can be transferred to chronic pain after other surgical procedures and therefore help us understand risk factors for chronic pain after surgery.

Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial.

BACKGROUND: A key point in pathways for optimal rehabilitation and enhanced recovery is an effective postoperative multimodal pain treatment regimen. OBJECTIVE: To investigate the analgesic effects of transversus abdominis plane (TAP) block in conjunction with paracetamol and ibuprofen in patients undergoing laparoscopic colonic resection. DESIGN: Randomised placebo-controlled double-blind study. SETTING: Herlev University Hospital, Copenhagen, Denmark, from March 2010 to February 2013. PATIENTS: Eighty adult patients scheduled for elective laparoscopic colectomy. INTERVENTIONS: Bilateral TAP block with 20 ml of either ropivacaine or isotonic saline. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) pain scores (0 to 100 mm) while coughing at 6 h after surgery (primary outcome). Secondary outcomes were area under the curve pain scores (2 to 24 h) at rest and while coughing, 24-h morphine consumption and incidence of nausea and vomiting. RESULTS: VAS pain scores at 6 h while coughing was not different between groups (median, interquartile range), TAP, 27 (11 to 45) mm vs. placebo, 33 (20 to 49) mm (P = 0.20). Total 24-h morphine consumption was reduced in the TAP block group vs. placebo group, 30 (15 to 41) mg vs. 43 (30 to 67) mg, respectively (P = 0.008). This difference was most pronounced in the first postoperative hours. The remaining outcomes did not differ between groups. CONCLUSION: TAP block used in combination with paracetamol and ibuprofen did not reduce pain after laparoscopic colonic surgery. However, we found a 30% reduction in opioid use, most marked in the early postoperative period. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01418144).

Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers.

BACKGROUND: The analgesic effect of a TAP block has been investigated in various surgical settings. There are however limited information about block level and block duration. Furthermore, there is a lack of information about continuous TAP block after ultrasound-guided posterior TAP blocks.The aim of this double-blind randomized study was therefore to investigate the effect of an ultrasound-guided posterior TAP block with 24 hours local anesthetic infusion via a TAP catheter. METHODS: In this randomized study 8 male volunteers received a bilateral TAP block (20 mLs 0.5% ropivacaine) and were allocated to receive active infusion (ropivacaine 0.2% 5 mL/hr) via a TAP catheter on one side and placebo infusion on the other side. PRIMARY OUTCOME: Dermatomal sensory block involvement after 24 hours evaluated with pinprick. SECONDARY OUTCOMES: Sensory block involvement evaluated with cold test and heat-pain detection thresholds (HPDT) on the abdominal wall. Assessment points: 15 min before block performance and 1, 4, 8, 12 and 24 hours after block performance. RESULTS: The TAP block primarily involved sensory changes in the Th10 to Th12 dermatomes. On the placebo side there was a decrease in extension beginning at 4-8 hours after block performance and with no detectable effect beyond 12 hours. Median number of dermatomes anesthetized (pinprick) at 24 hours after block performance was 1.5 (0-3) on the active side compared with 0 (0-0) on the placebo side (P = 0.039).There were no statistical significant between-side differences in HPDT measurements at 24 hours after block performance. CONCLUSIONS: The spread of sensory block following ultrasound-guided posterior TAP block is partly maintained by a continuous 24 hour ropivacaine infusion through a TAP catheter. TRIAL REGISTRATION: The study was registered at NCT01577940.

The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial.

CONTEXT: The analgesic effect of transversus abdominis plane (TAP) block after inguinal hernia repair is unclear. OBJECTIVE: The aim of this randomised and double-blind study was to evaluate the analgesic effect of a TAP block in patients scheduled for primary inguinal hernia repair. The TAP block was evaluated versus placebo and versus an active comparator (ilioinguinal block and wound infiltration). DESIGN: Randomised controlled trial. SETTING: Single centre trial. Study period from June 2010 to November 2011. PATIENTS: Adults (18 to 75 years) with American Society of Anesthesiologists' status 1-3 scheduled for primary inguinal hernia repair as day case surgery were included in the study. INTERVENTIONS: Ninety patients were allocated to one of three groups: group TAP, group infiltration (ilioinguinal nerve block and wound infiltration) and group placebo. MAIN OUTCOME MEASURES: The primary outcome measure was pain scores while coughing between group TAP and group placebo calculated as area under the curve for the first 24  h (AUC24 h). Secondary outcomes were pain scores while coughing and at rest, opioid consumption and side effects in groups TAP, infiltration and placebo. RESULTS: Visual analogue pain scores while coughing and at rest demonstrated no difference between groups. Pain scores in groups infiltration, TAP and placebo were 19 versus 22 versus 15  mm at rest (P = 1.00) and 37 versus 41 versus 37  mm while coughing (P = 1.00). Pain scores at 6 h (AUC6 h) were significantly lower in group infiltration than in group TAP (10 versus 25 mm at rest, P < 0.001; 17 versus 40  mm while coughing, P < 0.001), and than in group placebo (10 versus 20  mm at rest, P = 0.003; 17 versus 38  mm while coughing, P < 0.001). Median morphine consumption was lower in group infiltration than in group placebo (0 versus 5 mg, P < 0.003). No differences among groups were demonstrated for ketobemidone consumption or side effects. CONCLUSION: Ultrasound-guided TAP block did not reduce postoperative pain after inguinal hernia repair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01052285. EudraCT number 2010-018403-29.

Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial.

OBJECTIVE: For patients in intensive care units, sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis. The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation, guided by daily measurements of the biomarker procalcitonin, could reduce the time to appropriate therapy, thus improving survival. DESIGN: Randomized controlled open-label trial. SETTING: Nine multidisciplinary intensive care units across Denmark. PATIENTS: A total of 1,200 critically ill patients were included after meeting the following eligibility requirements: expected intensive care unit stay of ≥ 24 hrs, nonpregnant, judged to not be harmed by blood sampling, bilirubin <40 mg/dL, and triglycerides <1000 mg/dL (not suspensive). INTERVENTIONS: : Patients were randomized either to the "standard-of-care-only arm," receiving treatment according to the current international guidelines and blinded to procalcitonin levels, or to the "procalcitonin arm," in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements. MEASUREMENTS AND MAIN RESULTS: The primary end point was death from any cause at day 28; this occurred for 31.5% (190 of 604) patients in the procalcitonin arm and for 32.0% (191 of 596) patients in the standard-of-care-only arm (absolute risk reduction, 0.6%; 95% confidence interval [CI] -4.7% to 5.9%). Length of stay in the intensive care unit was increased by one day (p = .004) in the procalcitonin arm, the rate of mechanical ventilation per day in the intensive care unit increased 4.9% (95% CI, 3.0-6.7%), and the relative risk of days with estimated glomerular filtration rate <60 mL/min/1.73 m was 1.21 (95% CI, 1.15-1.27). CONCLUSIONS: Procalcitonin-guided antimicrobial escalation in the intensive care unit did not improve survival and did lead to organ-related harm and prolonged admission to the intensive care unit. The procalcitonin strategy like the one used in this trial cannot be recommended.

The Procalcitonin And Survival Study (PASS) - a randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients.

BACKGROUND: Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein) may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. METHODS: Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC)). Inclusion: 1) Age > or = 18 years of age, 2) Admitted to the participating intensive care units, 3) Signed written informed consent.Exclusion: 1) Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2) Likely that safety is compromised by blood sampling, 3) Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1), n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. DISCUSSION: For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival of critically ill patients be improved by actively using biomarker procalcitonin in the treatment of infections? 700 critically ill patients are currently included of 1000 planned (June 2008). Two interim analyses have been passed without any safety or futility issues, and the third interim analysis is soon to take place. Trial registration number at clinicaltrials.gov: Id. nr.: NCT00271752).