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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04902222
Enrollment
26
Registered
2021-05-26
Start date
2021-04-01
Completion date
2022-05-01
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension, Orthostatic Intolerance

Keywords

Orthostatic Hypotension, Orthostatic Intolerance, Morphine, Autonomic Dysfunction

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.

Interventions

DRUGMorphine

Administration of 0.1 mg/kg (IBW) intravenous morphine

Sponsors

Kehlet, Henrik, M.D., Ph.D.
CollaboratorINDIV
Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of orthostatic hypotension30 minutes after morphine administrationOrthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

Secondary

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

Other

MeasureTime frameDescription
Pain score during mobilisationBefore and 30 minutes after morphine administrationMeasured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)
Occurence of side-effects to morphine administration30 minutes after morphine administrationOccurrence of following side-effects to morphine administration: nausea, vomiting, pruritus, headache or dizziness

Countries

Denmark

Contacts

Primary ContactBodil Uldall-Hansen, BA Medicine
bodil.uldall-hansen@regionh.dk+4528342057
Backup ContactAna-Marija Hristovska, Resident
anamarijahristovska@gmail.com+4538621508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026