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Completed

NCT Number: NCT02483221

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

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

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Key information

Conditions

Acute Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydromorphone

Drug

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.

Morphine

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2015
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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