S70-S79
Conditions
Interventions
Group 1: Hip fracture surgery with standard care general anaesthesia
Group 2: Hip fracture surgery with standard care spinal anaesthesia
Sponsors
Klinik für Anästhesiologie, Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 65 years; signed informed consent; suffers from intra-/extracapsular hip fracture (e.g. femoral neck fracture, subtrochanteric or intertrochanteric fracture), planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate osteosynthetic procedure
Exclusion criteria
Exclusion criteria: People who are institutionalized by court or administrative order; planned concurrent surgery not amenable to spinal anaesthesia; absolute contraindications to spinal anaesthesia; periprosthetic fracture; prior participation in the iHOPE study; as determined by the attending surgeon, the attending anaesthesiologist, or the site principle investigator or their designate, that the patient or the attending team would not be suitable for a randomization procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test Efficacy of spinal versus general anaesthesia on allcause mortality and new-onset (i.e. not pre-existing at time of surgery) serious cardiac and pulmonary complications up to 30-days after hip fracture surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Difference in the proportion of patients alive and delirium free in the first 4 days after hip fracture surgery. Delirium will be assessed via in-person interview by the validated, high sensitive and specific assessment tool 3D-Confusion Assessment Method (3D-CAM). It will be applied at baseline and daily on the first 4 postoperative days. 2) Difference in the proportion of patients with postoperative pain; and in the characteristics and duration of postoperative pain between the two treatment arms. Pain will be assessed via numeric rating scale (NRS 0-10) and questions derived from the Brief Pain Inventory and the German pain questionnaire. Assessment will be performed via in-person interview at baseline and each postoperative visit during hospital stay. After discharge, it will be performed via telephone interview at each follow-up visit. 3) Difference in the satisfaction with care between the two treatment arms, assessed at day 4 or the day of discharge (whichever occurs first). The Bauer Patient Satisfaction Questionnaire will be used via in-person interview on postoperative day 4 or at discharge (whichever occurs first), to assess the patients´ satisfaction. 4) Difference in the number of in-hospital events, which include (but not limited to): Planned and unplanned admission to critical care; length of hospital and intensive care stay; length of hospital stay longer than expected; independence in walking and the need for assistive devices for walking at hospital discharge; postoperative hospital discharge destination; in hospital all-cause mortality and severe new-onset complications as those used by the NSQIP. These events will be assessed on the discharge day from hospital or at least at postoperative day 30 via in-person interview and medical record review. 5) Difference in the proportion or means of long-term outcomes at day 30 ± 3, day 180 ± 45 and day 365 ± 60 after randomization will include: All cause-mortality, independence in walking and ne | — |
Countries
Germany
Contacts
Public ContactMark Coburn
Universitätsklinikum Bonn Klinik für Anästhesiologie und Operative Intensivmedizin
Outcome results
None listed