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

Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery

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 Overview

• Status: Completed
• Conditions: Acute Postoperative Pain
• Intervention / Treatment: Drug: Hydromorphone; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Department of Anesthesiology, University Hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TCI-PCA	Drug: Hydromorphone; 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.
Active Comparator: PCA	Drug: Morphine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Score	Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	up to 17 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	day of surgery
Respiratory Frequency	Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	up to 17 hours after extubation

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Christian Jeleazcov, MD, MS, Department of Anesthesiology, University Hospital Erlangen

Publications and helpful links

General Publications

• Ihmsen H, Schuttler J, Jeleazcov C. Pharmacokinetics of Morphine and Morphine-6-Glucuronide During Postoperative Pain Therapy in Cardiac Surgery Patients. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):249-263. doi: 10.1007/s13318-020-00663-z. Epub 2021 Feb 5.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Hydromorphone
• Other Study ID Numbers: TCI-PCA-002