Adverse event reporting and harms {22}
death, bleeding, congenital anomaly, birth defect, disability or incapacity
BLEEDING, DELAYED WOUND HEALING, THROMBOEMBOLIC EVENT, ADVERSE EVENTS, WOUND INFECTION, COMPLICATIONS
Participant safety will be ensured via standard institutional protocols. The use of the GNRB is established to be safe in pre-operative [Serious adverse events (SAE) are defined as any untoward and unexpected medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing inpatients’ hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is any other important medical condition which, although not included in the above, may require medical or surgical intervention to prevent one of the outcomes listed. All SAEs will be reported to the approving ethics board within 72 h of the investigators becoming aware of them. SAEs that may be expected as part of the surgical interventions and that do not need to be reported to the HREC are complications of anaesthesia or surgery (wound infection, bleeding or damage to adjacent structures such as nerves, tendons and blood vessels, delayed wound healing, and thromboembolic events, femoral or tibial fracture).