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

Phase 4

Completed

• Conditions: Acute Postoperative Pain
• Interventions: Drug: Hydromorphone; Drug: Morphine

• Registration Number: NCT02483221
• 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-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCI-PCA	Hydromorphone	-
PCA	Morphine	-

Primary Outcome Measures

Name	Time	Method
Numerical Rating Score	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 Outcome Measures

Name	Time	Method
Respiratory Frequency	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
Modified Observer's Assessment of Alertness/Sedation Scale	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
Postoperative Nausea and Vomiting	day of surgery	Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage

Trial Locations

Locations (1)

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