Clinical trial NCT04902222: Orthostatic Intolerance and Hypotension After Administration of Morphine in Patients Prior to Hip or Knee Arthroplasty
Official title: Incidence of Orthostatic Intolerance and Orthostatic Hypotension After Administration of Intravenous Morphine in Patients Prior to Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Hypotension
Orthostatic Intolerance
Keywords: Orthostatic Hypotension
Orthostatic Intolerance
Morphine
Autonomic Dysfunction
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2021-05-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary unilateral total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of orthostatic hypotension
timeFrame: 30 minutes after morphine administration
Secondary outcomes:
measure: Changes in systolic arterial pressure (SAP) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in diastolic arterial pressure (DAP) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in mean arterial pressure (MAP) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in heart rate (HR) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in stroke volume (SV) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in cardiac output (CO) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in systemic vascular resistance (SVR) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in peripheral perfusion index (PPI) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in cerebral perfusion (ScO2) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in muscular perfusion (SmO2) during mobilization
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
timeFrame: Before and 30 minutes after morphine administration
measure: Changes in heart rate variability (HRV) during Valsalva manoeuvre
timeFrame: Before and 30 minutes after morphine administration
Other outcomes:
measure: Pain score during mobilisation
timeFrame: Before and 30 minutes after morphine administration
measure: Occurence of side-effects to morphine administration
timeFrame: 30 minutes after morphine administration
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Nicolai Bang Foss, Dr. Med.
role: STUDY_DIRECTOR
References: