Orthostatic Intolerance and Hypotension After Administration of Morphine in Patients Prior to Hip or Knee Arthroplasty

Overview

Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty.

Full Title of Study: “Incidence of Orthostatic Intolerance and Orthostatic Hypotension After Administration of Intravenous Morphine in Patients Prior to Hip or Knee Arthroplasty”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2022

Detailed Description

Early postoperative mobilization is crucial for recovery of patients undergoing surgery in the multimodal fast-track approach to perioperative care, since physical immobilization is highly associated with increased risk of postoperative complications and prolonged hospital length of stay. Postoperative mobilization is often delayed due to patients experiencing orthostatic hypotension (OH), defined as a drop in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg, or orthostatic intolerance (OI), characterized by dizziness, blurred vision, nausea, vomiting, sensation of heat or syncope. Previous studies have found a high incidence of postoperative OI (> 40 %) among patients undergoing total hip arthroplasty. A possible causative factor to the high occurrence of OH and OI after surgery could be postoperative pain management by administration of morphine. Morphine is known to have many side-effects including nausea, vomiting, dizziness and orthostatic hypotension. The object of this study is to isolate and estimate the effect of intravenous morphine on the incidence of OH and OI.

Interventions

  • Drug: Morphine
    • Administration of 0.1 mg/kg (IBW) intravenous morphine

Arms, Groups and Cohorts

  • Patients undergoing primary hip or knee arthroplasty
    • Patients undergoing primary hip or knee arthroplasty

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of orthostatic hypotension
    • Time Frame: 30 minutes after morphine administration
    • Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization

Secondary Measures

  • Changes in systolic arterial pressure (SAP) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
  • Changes in diastolic arterial pressure (DAP) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in mmHg by non-invasive LiDCO
  • Changes in mean arterial pressure (MAP) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in mmHg by non-invasive LiDCO
  • Changes in heart rate (HR) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in beats min-1 by non-invasive LiDCO
  • Changes in stroke volume (SV) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in mL by non-invasive LiDCO
  • Changes in cardiac output (CO) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in L/min by non-invasive LiDCO
  • Changes in systemic vascular resistance (SVR) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in dynes s cm-5 by non-invasive LiDCO
  • Changes in peripheral perfusion index (PPI) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in % by Root Masimo
  • Changes in cerebral perfusion (ScO2) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in % by Root Masimo
  • Changes in muscular perfusion (SmO2) during mobilization
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in % by Root Masimo
  • Changes in baroreflex sensitivity – vagal (BRSv) during Valsalva manoeuvre
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in ms
  • Changes in heart rate variability (HRV) during Valsalva manoeuvre
    • Time Frame: Before and 30 minutes after morphine administration
    • Measured in ms

Participating in This Clinical Trial

Inclusion Criteria

  • Patients undergoing primary unilateral total hip arthroplasty (THA), total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA) – Patients > 18 – Patients that understand and speak Danish – Patients that have provided written informed consent Exclusion Criteria:

  • Alcohol or substance abuse – Habitual use of opioids – Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs – History of previous orthostatic intolerance or hypotension – Cognitive dysfunction – Glomerular filtration rate (GFR) < 30 ml/min – Cardiac arrhythmia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Copenhagen University Hospital, Hvidovre
  • Collaborator
    • Henrik Kehlet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bodil Uldall-Hansen, Research assistant – Copenhagen University Hospital, Hvidovre
  • Overall Official(s)
    • Nicolai Bang Foss, Dr. Med., Study Director, Copenhagen University Hospital, Hvidovre
  • Overall Contact(s)
    • Bodil Uldall-Hansen, BA Medicine, +4528342057, bodil.uldall-hansen@regionh.dk

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