Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

Phase 4CompletedNCT02035709

University of Erlangen-Nürnberg Medical School50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postoperative Pain

Interventions

HydromorphoneDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, Germany

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Germany

Outcomes

Primary Outcomes

Hydromorphone Plasma Concentrations

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

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

Secondary Outcomes

Numerical Rating Score

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

Data from ClinicalTrials.gov

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