Incidence of neuraxial haematoma after total hip or knee surgery: RECORD programme (rivaroxaban vs. enoxaparin)

Acta Anaesthesiol Scand. 2013 May;57(5):565-72. doi: 10.1111/aas.12069. Epub 2013 Jan 21.

Abstract

Background: Patients receiving anticoagulants could be at higher risk of compressive haematoma with neuraxial anaesthesia use. The phase III RECORD programme compared rivaroxaban with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement surgery in more than 12,500 patients. This observational analysis evaluated the risk of neuraxial haematoma after neuraxial anaesthesia in patients receiving rivaroxaban or enoxaparin using pooled RECORD1-4 data.

Methods: The incidences of intraspinal bleeding or haemorrhagic puncture were recorded as part of the criteria for major bleeding (the primary safety outcome in the RECORD studies). Incidences of allogeneic transfusion and venous thromboembolism by type of anaesthesia were also recorded.

Results: No compressive haematomas occurred in rivaroxaban-treated patients (10 mg once daily started 6-8 h after surgery) who underwent neuraxial anaesthesia (n = 4086). Among enoxaparin-treated patients (n = 4090), one compressive spinal haematoma requiring laminectomy occurred after epidural catheter removal in an elderly female patient with renal insufficiency undergoing total knee replacement. Total venous thromboembolism rates did not differ according to type of anaesthesia.

Conclusion: Although no issues were observed with the use of neuraxial anaesthesia in this population of 4086 patients receiving rivaroxaban after total hip or knee replacement, it is important to remain aware of the risk of compressive haematoma. This may be of particular concern in elderly patients with renal insufficiency receiving an anticoagulant predominantly eliminated via the kidneys.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anticoagulants / adverse effects
  • Arthroplasty, Replacement, Hip*
  • Arthroplasty, Replacement, Knee*
  • Enoxaparin / adverse effects*
  • Female
  • Hematoma / epidemiology*
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Morpholines / adverse effects*
  • Postoperative Complications / epidemiology
  • Rivaroxaban
  • Thiophenes / adverse effects*
  • Venous Thromboembolism / epidemiology

Substances

  • Anticoagulants
  • Enoxaparin
  • Morpholines
  • Thiophenes
  • Rivaroxaban