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Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA

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ClinicalTrials.gov Identifier: NCT02483221
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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

Condition or disease Intervention/treatment Phase
Acute Postoperative Pain Drug: Hydromorphone Drug: Morphine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TCI-PCA Drug: Hydromorphone
Hydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed.

Active Comparator: PCA Drug: Morphine
Morphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Modified Observer's Assessment of Alertness/Sedation Scale [ Time Frame: up to 17 hours after extubation ]
    Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

  2. Postoperative Nausea and Vomiting [ Time Frame: day of surgery ]
    Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

  3. Respiratory Frequency [ Time Frame: up to 17 hours after extubation ]
    Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483221


Locations
Germany
Department of Anesthesiology, University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christian Jeleazcov, MD, MS Department of Anesthesiology, University Hospital Erlangen

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02483221     History of Changes
Other Study ID Numbers: TCI-PCA-002
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents