Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Hydromorphone

• Registration Number: NCT02035709
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-02
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCI-PCA	Hydromorphone	Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion
PCA	Hydromorphone	Intravenous Patient-Controlled Analgesia

Primary Outcome Measures

Name	Time	Method
Hydromorphone Plasma Concentrations	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 Outcome Measures

Name	Time	Method
Numerical Rating Score	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

Trial Locations

Locations (1)

Department of Anesthesiology, University Hospital Erlangen; 🇩🇪 Erlangen, Germany