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. 2016 Feb 22;2016(2):CD000521. doi: 10.1002/14651858.CD000521.pub3

NCT02507505.

Trial name or title Regional versus General Anesthesia for Promoting Independence after Hip Fracture (REGAIN): protocol for a pragmatic, international multicentre trial
Ethics boards approval obtained
Methods RCT, multicenter
Participants 1600 previously ambulatory participants aged 50 and older with a clinically or radiographically diagnosed intra‐ or extracapsular hip fracture and planned surgical treatment via hemiarthoplasty, total hip arthroplasty or appropriate fixation procedure
Excluion criteria: planned concurrent surgery not amenable to spinal anaesthesia, contraindications to spinal anaesthesia, known susceptibility to malignant hyperthermia, periprosthetic fracture, prior participation to this trial, prisoner status or not being suitable for randomisation
Interventions Intervention: spinal anaesthesia
Control: general anaesthesia
Outcomes
  • Composite of death, new inability to walk 10 feet or across room at 60 days (blind assessor)

  • Delirium (in‐hospital)

  • Major inpatient hospital complication (in‐hospital)

  • Mortality (in‐hospital, 60, 180 and 365 days)

  • Acute postoperative pain (in‐hospital)

  • Patient satisfaction (in‐hospital)

  • Length of hospital stay (in‐hospital)

  • Disease‐free survival (60, 180 and 365 days)

  • Chronic pain (60, 180 and 365 days)

  • Return to pre‐fracture residence (60, 180 and 365 days)

  • Need for new assistive device for ambulation (60, 180 and 365 days)

  • Cognitive impairment (60, 180 and 365 days)

Starting date Recruitment began in February 2016 and will continue until the end of 2019
Contact information Mark D Neuman
Notes Expected results late 2020

BIS: bispectral index; CAM: Confusion Assessment Method ; mcg/kg: micrograms per kilogram of body weight; mL; millilitres; RCT: randomized controlled trial