Postoperative Pain Therapy With Hydromorphone Using TCI-PCA (TCI-PCA)

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

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 Overview

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

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

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Department of Anesthesiology, University Hospital Erlangen
  • 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
• 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 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; Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion	Drug: Hydromorphone; 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.
Active Comparator: PCA; Intravenous Patient-Controlled Analgesia	Drug: Hydromorphone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Score	Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Hydromorphone Administered	Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding the amount of hydromorphone administered	Day 1 (Visit 3 on first day after surgery)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05.
• Wehrfritz A, Ihmsen H, Fuchte T, Kim M, Kremer S, Weiss A, Schuttler J, Jeleazcov C. Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1168-1175. doi: 10.1097/EJA.0000000000001360.
• Ihmsen H, Rohde D, Schuttler J, Jeleazcov C. External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy. Eur J Drug Metab Pharmacokinet. 2017 Feb;42(1):17-28. doi: 10.1007/s13318-015-0318-x.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 2, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Therapy
• 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; Hydromorphone
• Other Study ID Numbers: TCI-PCA-001; 2013-002875-16 (EudraCT Number)