Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2).

BACKGROUND: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain. METHODS: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as 'worst chest pain over the last week' equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis. DISCUSSION: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS. TRIAL REGISTRATION: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856 . First patient recruited 8 January 2019.

Veno-venous extracorporeal membrane oxygenation used as an adjunct in the surgical management of acquired and iatrogenic tracheobronchial pathology.

BACKGROUND: Surgical repair of tracheobronchial tree injuries is challenging due to the difficulties associated with providing perioperative ventilatory support. Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is a recognized treatment modality for managing respiratory failure. Its use has expanded to include offering respiratory support for patients requiring surgery on the tracheobronchial tree. This study presents our experience with V-V ECMO support for elective and emergency surgery for acquired and iatrogenic tracheobronchial pathology. METHODS: A retrospective review of our single-center experience of surgical tracheobronchial repairs where V-V ECMO was employed between 2017 and 2020 was undertaken. Preoperative patient characteristics, intraoperative findings, details of ECMO support and postoperative outcomes were collected and analyzed. RESULTS: Five patients underwent surgery with V-V ECMO support during the study period. Indications for surgery included repair of iatrogenic tracheal tear (N.=2), repair of iatrogenic gastro-bronchial fistula (N.=1), elective tracheoplasty (N.=1) and elective resection of tracheal tumor (N.=1). The median duration of V-V ECMO was 17 hours (range: 4-543 hours), and the median postoperative length of stay was 9 days (range: 7-19 days). In-hospital and 90-day mortality were both 0% (N.=0). Postoperative complications included reoperation for bleeding (N.=1) and thrombotic complications (N.=2). CONCLUSIONS: We have shown how V-V ECMO can be safely utilized to manage patients with a range of tracheobronchial injuries with low rates of postoperative morbidity. Acceptable postoperative outcomes can be achieved for this cohort of clinically complex patients when treatment is provided with a multidisciplinary team approach in high-volume specialist centers.

Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial.

OBJECTIVES: Thoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB. DESIGN: A randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible. SETTING: Two adult thoracic centres in the UK. PARTICIPANTS: All adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy. RESULTS: All patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns. CONCLUSIONS: A large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably. TRIAL REGISTRATION NUMBER: ISRCTN45041624.

Extracorporeal membrane oxygenation in severe respiratory failure resulting from burns and smoke inhalation injury.

Extracorporeal membrane oxygenation (ECMO) is one of the most frequent forms of extracorporeal life support (ECLS) and can be used as rescue therapy in patients with severe respiratory failure resulting from burns and/or smoke inhalation injury. Experience and literature on this treatment option is still very limited, consequently results are varied. We report a retrospective analysis of our experience with veno-venous (VV) ECMO in burn patients. All five patients, three male and two female (age: 28-37 years) had flame type burns and smoke inhalation injury. Their Murray scores ranged between 3.25 and 3.75, and their revised Baux scores between 62 and 102. The mean pre-ECMO conventional ventilation time was 7.4days (3-13). The mean ECMO duration was 18days (8-35). Three patients were cannulated with dual lumen, two with separate cannulae. One oxygenator had to be changed due to technical issues and two patients needed two parallel oxygenators. Four patients had renal replacement therapy. All patients needed vasoconstrictor support, antibiotics and packed red blood cells (5-62 units). Three had steroid treatment. All five patients were successfully weaned from ECMO. One patient died later from multi-organ failure in the ICU, the other four patients survived. VV-ECMO is a useful rescue intervention in patients with burns related severe respiratory failure. Patients in our institution benefit from having both burns and ECMO centres with major expertise in the field under one roof. The results from this small cohort are encouraging, although more cases are needed to draw more robust conclusions.

Chronic mould exposure as a risk factor for severe community acquired pneumonia in a patient requiring extra corporeal membrane oxygenation.

A previously fit and well man developed acute respiratory failure due to environmental mould exposure from living in damp rental accommodation. Despite aggressive intensive care management he rapidly deteriorated and required respiratory and cardiac Extracorporeal Membrane Oxygenation. We hypothesize that poor domiciliary conditions may make an underestimated contribution to community respiratory disease. These conditions may present as acute and severe illness with non-typical pathogens identified.

[Anticoagulation with hirudin for repeat cardiac surgery in a patient with heparin induced thrombocytopaenia]. / Hirudinnal végzett alvadásgátlás heparin kiváltotta thrombocytopeniában harmadik szívmutét során.

UNLABELLED: The authors present the case of a patient with heparin induced thrombocytopaenia who needed anticoagulation during the perioperative period of a third repeat cardiac operation without transfusions. Prostacyclin pretreatment was contraindicated because of critical aortic stenosis, heparinoids could not have been used due to necessity of postoperative anticoagulation. Recombinant hirudin was applied and its effect was monitored with ekarin coagulation time. Hirudin anticoagulation was continued until the proper INR was reached in the postoperative period. There were no intra- and postoperative complications detected, and there was no need for transfusion either. On his long-term follow-up, 6.5 years after the last cardiac surgery the patients was feeling well and had no complaints. CONCLUSION: Open heart operation of a patient with heparin induced thrombocythopenia can be performed safely by total anticoagulation with lepirudin if it is conducted by ecarin clotting time.

[Intraoperative fires caused by alcoholic skin antiseptic and diathermy]. / Alkoholtartalmú borfertotlenítok és diathermia okozta égések sebészi beavatkozások során.

UNLABELLED: The authors describe two intraoperative fires during cardiac surgery. In both cases, in addition to the usual disinfection and isolation of the operating field, they wanted to reduce the infection hazard and to restore the partly ruined isolation by 70% alcoholic skin antiseptic solution. Soon after the disinfection, but before the evaporation of alcohol, diathermy was used and caused fire. In case of the first patient the fire spread over the isolation film and resulted second grade (5%) and third-grade (1%) burn injury which required plastic surgery. In the second case the patient's beard caught fire causing second-grade (1%) burn that was treated locally. Despite these burn injuries both patients recovered after the heart surgery. These two intraoperative fires are 0.003-0.004% of all surgical procedures. CONCLUSION: Fires during surgery are rare and might have serious consequences. They can be prevented by keeping the discipline of work and instructions of fire protection. The best way of prevention is regular education of all the staff (doctors, nurses, etc.) working in the operating theatre.

Soluble ST2 protein in cardiac surgery: a possible negative feedback loop to prevent uncontrolled inflammatory reactions.

BACKGROUND: Recent reports have demonstrated that cardiopulmonary bypass (CBP) utilization leads to a TH2 cytokine bias in patients undergoing coronary artery bypass grafting (CABG) operation. The relation of soluble ST2 and secretion of IL-10, markers of TH2 T-cell activation, and IL-13 in relation to immunoglobulin isotope production is not known in patients undergoing On- versus Off-pump (CABG) procedure. METHODS: 30 patients were prospectively included in the study (On- vs Off-pump CABG, each n = 15). Serum samples were obtained prior to, and 30 min, 60 min and 24hrs after operation. ELISA was utilized to detect sST2 and IL-10, IL-13 and immunoglobulin isotype production. RESULTS: In both cohorts we could demonstrate a significant rise of ST2 24 hours after the CABG procedure. In the On-pump group ST2 levels (pg/ml) before the operation, at 30 and 60 minutes and after 24 hours were 115.3 +/- 25, 71.2 +/- 15, 114.1 +/- 26 and 4231.9 +/- 520, respectively. In the Off-pump group they were 200.3 +/- 109, 91.2 +/- 20, 137 +/- 29 and 4144.9 +/- 488 (both, p < 0.0001, p < 0.0001, respectively). IL-10 (pg/ml) levels rose from preoperative values of 6.2 +/- 1.6 in the On-pump group and 7.91 +/- 1.8 in the Off-pump group to 33.14 +/- 8.7 and 13.72 +/- 3 after 60 minutes (p 0.0189, p 0.0397, respectively). IL-13 levels and immunoglobulin production did not change significantly within the study period irrespective of the operation procedure used. CONCLUSION: In conclusion, our results demonstrate that sST2 and IL-10, markers of TH2 cytokine producing cells, are increased in CABG operation, irrespective of the procedure selected, and settles a longstanding controversy concerning the shift from Th1 to Th2 cells.

[Surgery of aortic valve stenosis with porcelain aorta under hypothermic circulatory arrest]. / Porcelánaortával szövódött aortabillentyú-hiba mútéte teljes keringésmegállítással.

This is a case report of a 52 year-old male patient with severe calcific aortic valve stenosis, associated with extended circular calcification of the ascending aorta and the aortic arch. Six months ago the patient underwent an explorative sternotomy in another institute, but the aortic valve replacement was not performed regarding the great risk of the porcelain aorta. The patient's complaints became more severe, so the authors recommended the excision both of the stenotic aortic valve and the calcified ascending aorta and replacement with a mechanical valve and vascular prosthesis. The operation was performed in deep hypothermia and total circulatory arrest with help of cardiopulmonary bypass. The calcified ascending aorta was excised without crossclamping. The vascular graft used for replacement of the ascending aorta was anastomosed to the proximal part of the aortic arch, then it was clamped and the extracorporal circulation was started again with rewarming of the patient. The aortic valve was replaced with a 21 mm St. Jude HP mechanical valve prosthesis in the usual manner. At last, the graft was anastomosed supracoronary to the proximal stump of the ascending aorta. Extracorporal circulation was discontinued without any difficulties. Apart from a few days of somnolence, the patient's recovery was uneventful, he was discharged from hospital on the 12th postoperative day. Three months after the surgery he had no complaints and returned to work without any problems.

[Surgical treatment of malignant renal tumors invading the inferior vena cava and right atrium]. / Vena cava inferioron át a jobb pitvarba terjedó rosszindulatú vesedaganatok sebészi kezelése.

Invading the inferior vena cava and right atrium is the most serious, but fortunately not common complication of renal cell carcinoma. Radical nephrectomy with tumor-thrombus extraction is the only way to improve these patients survival. Cardiopulmonary bypass with or without deep hypothermia and total circulatory arrest might be necessary during surgery. Between 1998 and 2003 at the Department of Cardiac Surgery of University of Debrecen, 5 patients, with renal cell carcinoma extending into the right atrium, had radical nephrectomy and thrombectomy. We used cardiopulmonary bypass, in 2 patients in total circulatory arrest, in deep hypothermia. There was no operative death and neurological complications. One patient died 3 years after the operation due to cardiac failure. In average 42 months after surgery, 4 surviving patients are under regular follow up, they have a good quality of life, without recurrence. In our opinion cardiopulmonary bypass and total circulatory arrest, if necessary, gives the best way for surgical resection of renal cell carcinoma extending into the right atrium.