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

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902222
• Other study ID #: H-20071567
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2021
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Bodil Uldall-Hansen, BA Medicine
• Phone: +4528342057
• Email: bodil.uldall-hansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Orthostatic Intolerance

Intervention

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

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Henrik Kehlet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score during mobilisation	Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)	Before and 30 minutes after morphine administration
Other	Occurence of side-effects to morphine administration	Occurrence of following side-effects to morphine administration: nausea, vomiting, pruritus, headache or dizziness	30 minutes after morphine administration
Primary	Incidence of orthostatic hypotension	Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization	30 minutes after morphine administration
Secondary	Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement	Before and 30 minutes after morphine administration
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in heart rate (HR) during mobilization	Measured in beats min-1 by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in cardiac output (CO) during mobilization	Measured in L/min by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in systemic vascular resistance (SVR) during mobilization	Measured in dynes s cm-5 by non-invasive LiDCO	Before and 30 minutes after morphine administration
Secondary	Changes in peripheral perfusion index (PPI) during mobilization	Measured in % by Root Masimo	Before and 30 minutes after morphine administration
Secondary	Changes in cerebral perfusion (ScO2) during mobilization	Measured in % by Root Masimo	Before and 30 minutes after morphine administration
Secondary	Changes in muscular perfusion (SmO2) during mobilization	Measured in % by Root Masimo	Before and 30 minutes after morphine administration
Secondary	Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre	Measured in ms	Before and 30 minutes after morphine administration
Secondary	Changes in heart rate variability (HRV) during Valsalva manoeuvre	Measured in ms	Before and 30 minutes after morphine administration