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

Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Incidence of orthostatic hypotension

Secondary Outcome

 Changes in systolic arterial pressure (SAP) during mobilization

Condition

Orthostatic Hypotension

Intervention

Morphine

Study Arms / Comparison Groups

 Patients undergoing primary hip or knee arthroplasty
Description:  Patients undergoing primary hip or knee arthroplasty

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

26

Start Date

April 1, 2021

Completion Date

May 1, 2022

Primary Completion Date

May 1, 2022

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
      

Gender

All

Ages

18 Years - N/A


Contacts

Nicolai Bang Foss, Dr. Med., +4528342057, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04902222

Organization ID

H-20071567


Responsible Party

Principal Investigator

Study Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

 Kehlet, Henrik, M.D., Ph.D.

Study Sponsor

Nicolai Bang Foss, Dr. Med., Study Director, Copenhagen University Hospital, Hvidovre


Verification Date

June 2021