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Completed

NCT Number: NCT02035709

Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery

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Key information

Conditions

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, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent
  • Age between 40 and 85 years, both genders
  • Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay

Exclusion criteria

  • Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery
  • Administration of hydromorphone in the period between screening and surgery
  • Severe hepatic or renal impairment in medical history
  • BMI ≥35 kg/m²
  • ASA ≥4

Treatment and study plan

Hydromorphone

Drug

Hydromorphone is given by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times and infusion speed.

Primary outcomes

  1. Hydromorphone Plasma Concentrations

    Time frame: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation

    Predictive accuracy of the "Erlanger pharmacokinetic model" of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage

Secondary outcomes

  1. Numerical Rating Score

    Time frame: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation

    Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency

Other outcomes

  1. Amount of Hydromorphone Administered

    Time frame: Day 1 (Visit 3 on first day after surgery)

    Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding the amount of hydromorphone administered

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) After Elective Cardiac Surgery

Acronym: TCI-PCA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2014
Registry last updated
Jul 3, 2015

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

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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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