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Clinical Trials/NCT02483221
NCT02483221CompletedPhase 4

Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery

University of Erlangen-Nürnberg Medical School1 site in 1 country50 target enrollmentStarted: April 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Numerical Rating Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Written informed consent
  • •Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay

Exclusion Criteria

  • •Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
  • •Administration of hydromorphone or morphine in the period between screening and surgery
  • •Severe hepatic or renal impairment in medical history
  • •BMI>= 35 ASA>= 4

Arms & Interventions

TCI-PCA

Active Comparator

Intervention: Hydromorphone (Drug)

PCA

Active Comparator

Intervention: Morphine (Drug)

Outcomes

Primary Outcomes

Numerical Rating Score

Time Frame: up to 17 hours after extubation

Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

Secondary Outcomes

  • Respiratory Frequency(up to 17 hours after extubation)
  • Modified Observer's Assessment of Alertness/Sedation Scale(up to 17 hours after extubation)
  • Postoperative Nausea and Vomiting(day of surgery)

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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