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

NCT ID: NCT04902222

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Orthostatic Hypotension Orthostatic Intolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing primary hip or knee arthroplasty

Patients undergoing primary hip or knee arthroplasty

Morphine

Intervention Type DRUG

Administration of 0.1 mg/kg (IBW) intravenous morphine

Interventions

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Morphine

Administration of 0.1 mg/kg (IBW) intravenous morphine

Intervention Type DRUG

Other Intervention Names

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opioid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDIV

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Bodil Uldall-Hansen

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolai Bang Foss, Dr. Med.

Role: STUDY_DIRECTOR

Copenhagen University Hospital, Hvidovre

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Bodil Uldall-Hansen, BA Medicine

Role: CONTACT

+4528342057

Ana-Marija Hristovska, Resident

Role: CONTACT

+4538621508

Facility Contacts

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Bodil Uldall-Hansen, BA Medicine

Role: primary

+4528342057

Ana-Marija Hristovska, Resident

Role: backup

+4538621508

Other Identifiers

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H-20071567

Identifier Type: -

Identifier Source: org_study_id

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