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

University of Erlangen-Nürnberg Medical School50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Postoperative Pain

Interventions

HydromorphoneDRUG

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.

MorphineDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, Germany

Outcomes

Primary Outcomes

Numerical Rating Score

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

Time frame: up to 17 hours after extubation

Secondary Outcomes

Modified Observer's Assessment of Alertness/Sedation Scale

Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

Time frame: up to 17 hours after extubation

Postoperative Nausea and Vomiting

Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

Time frame: day of surgery

Respiratory Frequency

Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

Time frame: up to 17 hours after extubation

Data from ClinicalTrials.gov

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