Search

BackgroundBreast reconstruction is an integral part of breast cancer care. There are 2 main types of breast reconstruction: alloplastic (using implants) and autologous (using the patient’s own tissue). The latter creates a more natural breast mound and avoids the long-term need for surgical revision—more often associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is considered the gold standard approach in autologous breast reconstruction. However, complications do occur with DIEP flap surgery and can stem from poor flap tissue perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (eg, goal-directed perioperative fluid therapy) is essential. Current perioperative fluid therapy is traditionally guided by subjective criteria, which leads to wide variations in clinical practice. ObjectiveThe main objective of this trial is to determine whether the use of minimally invasive cardiac output (CO) monitoring for guiding intravenous fluid administration, combined with low-dose dobutamine infusion (via a treatment algorithm), will increase tissue oxygenation in patients undergoing DIEP flap surgery. MethodsWith appropriate institutional ethics board and Health Canada approval, patients undergoing DIEP flap surgery are randomly assigned to receive CO monitoring for the guidance of intraoperative fluid therapy in addition to a low-dose dobutamine infusion (which potentially improves flap oxygenation) versus the current standard of care. The primary outcome is tissue oxygenation measured via near-infrared spectroscopy at the perfusion zone furthest from the perforator vessels 45 minutes after vascular reanastomosis of the DIEP flap. Low dose (2.5 μg/kg/hr) dobutamine infusion continues for up to 4 hours postoperatively, provided there are no associated complications (ie, persistent tachycardia). Flap oxygenation, hemodynamic parameters, and any medication-associated side effects/complications are monitored for up to 48 hours postoperatively. Complications, rehospitalizations, and patient satisfaction are also collected until 30 days postoperatively. ResultsFunding and regulatory approvals were obtained in 2019, but the study recruitment was interrupted by the COVID-19 pandemic. As of October 4, 2023, 34 participants have been recruited. Because of the significant delays associated with the pandemic, the expected completion date was extended. We expect the study to be completed and ready for potential news release (as appropriate) and publication by July 2024. No patients have suffered any adverse effects/complications from participating in this study, and none have been lost to follow-up. ConclusionsCO-directed fluid therapy in combination with a low-dose dobutamine infusion via a treatment algorithm has the potential to improve DIEP flap tissue oxygenation and reduce complications following DIEP flap breast reconstruction surgery. However, given that the investigators remain blinded to group randomization, no comment can be made regarding the efficacy of this intervention for improving tissue oxygenation at this time. Nevertheless, no patients have been withdrawn for safety concerns thus far, and compliance remains high. Trial RegistrationClinicaltrials.gov NCT04020172; https://clinicaltrials.gov/study/NCT04020172

Background Perioperative thoracic epidural analgesia (TEA) is commonly used in hepatectomy patients since it is opioid-sparing. However, TEA has a high failure rate and is associated with potentially devastating complications (spinal haematoma) and the risk is increased with hepatectomy. Thus, some centres favour systemic opioid-based modalities which, in turn, are associated with inferior analgesia and well-known risks/side-effects. Hence, alternative analgesic methods are desirable. Paravertebral block (PVB) has been used in liver resection with advantages including haemodynamic stability, low failure rates, and low risk of spinal haematoma. The purpose of this pilot RCT is to compare continuous TEA (traditional standard of care is local anesthetic (LA) + opioids) with PVB (traditional standard of care is with LA without opioid) for patients undergoing hepatectomy. We hypothesise that pain outcomes will be comparable between groups, but PVB patients will require fewer perioperative vasopressors/blood products, have fewer opioid-related side effects and a shorter hospital length of stay. Methods With ethics approval, this non-inferiority, pilot RCT with a convenience sample of 50 hepatectomy patients will examine whether PVB imparts analgesia comparable to TEA but with fewer adverse effects. Primary outcomes are surrogates of analgesia for 72 h postoperatively (i.e., opioid consumption, time to first analgesic request and pain scores at rest and with coughing); Secondary outcomes are blood products/fluids administered; side effects/complications until 72 h postoperatively; length of hospital stay. The results will be used to plan a large multicentre trial comparing TEA vs. PVB in hepatectomy patients. This study has a high potential to positively impact the quality/safety of patient care. ClinicalTrials.gov registration NCT02909322 (09-21-2016); Available at URL: https://clinicaltrials.gov/ct2/show/NCT0290932

Background Perioperative thoracic epidural analgesia (TEA) is commonly used in hepatectomy patients since it is opioid-sparing and reduces cardiorespiratory complications. However, TEA has a high failure rate and is associated with potentially devastating complications (particularly spinal haematoma) and the risk is increased with hepatectomy. Thus, some centres favour systemic opioid-based modalities which, in turn, are associated with inferior analgesia and well-known risks/side-effects. Hence, alternative analgesic methods are desirable. Paravertebral block (PVB) has been used in liver resection with advantages including haemodynamic stability, low failure rates, and low risk of spinal haematoma. Our purpose is to conduct a blinded, pilot RCT with hepatectomy patients randomised to receive TEA or PVB for perioperative analgesia. We hypothesise that opioid consumption, time to first analgesic request, and pain scores will be comparable between groups, but PVB patients will require fewer perioperative vasopressors/blood products, and have fewer adverse events and a shorter hospital stay. Methods With ethics approval, this non-inferiority, pilot RCT with a convenience sample of 50 hepatectomy patients will examine whether PVB imparts analgesia comparable to TEA but with fewer adverse effects. Primary outcomes are surrogates of analgesia for 72 h postoperatively (i.e., opioid consumption, time to first analgesic request and pain scores at rest and with coughing); Secondary outcomes are blood products/fluids administered; side effects/complications until 72 h postoperatively; length of hospital stay. The results will be used to plan a large multicentre trial comparing TEA vs. PVB in hepatectomy patients. This study has a high potential to positively impact the quality/safety of patient care. ClinicalTrials.gov registration NCT02909322 (09-21-2016); Available at URL: https://clinicaltrials.gov/ct2/show/NCT0290932

Background: Perioperative thoracic epidural analgesia (TEA) is commonly used in hepatectomy patients since it is opioid-sparing and reduces cardiorespiratory complications. However, TEA has a high failure rate and is associated with potentially devastating complications (particularly spinal haematoma) and the risk is likely increased with hepatectomy. Thus, some centres favour systemic opioid-based modalities which, in turn, are associated with inferior analgesia and well-known risks/side-effects. Hence, alternative analgesic methods are desirable. Paravertebral block (PVB) has been used in liver resection with advantages including hemodynamic stability, low failure rates, and low risk of spinal haematoma. Our purpose is to conduct a blinded, pilot RCT with hepatectomy patients randomised to receive TEA or PVB for perioperative analgesia. Our hypothesis is that opioid consumption, time to first analgesic request, and pain scores will be comparable between groups, but PVB patients will require fewer perioperative vasopressors/blood products, and have fewer adverse events and a shorter hospital stay. Methods: With ethics approval, this non-inferiority, pilot RCT with a convenience sample of 50 hepatectomy patients will examine whether PVB imparts analgesia comparable to TEA but with fewer adverse effects. Primary outcomes are surrogates of analgesia for 72 h postoperatively (i.e., opioid consumption, time to first analgesic request and pain scores at rest and with coughing); Secondary outcomes are blood products/fluids administered; side effects/complications until 72 h postoperatively; length of hospital stay. The results will be used to plan a large multicentre trial comparing TEA vs. PVB in hepatectomy patients. This study has a high potential to positively impact the quality/safety of patient care. ClinicalTrials.gov registration: NCT02909322 (09-21-2016); Available at URL: https://clinicaltrials.gov/ct2/show/NCT0290932