Back to resultsPostoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA
Primary Purpose
Acute Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Hydromorphone
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology, University Hospital Erlangen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TCI-PCA
PCA
Arm Description
Outcomes
Primary Outcome Measures
Numerical Rating Score
Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Secondary Outcome Measures
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
Postoperative Nausea and Vomiting
Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Respiratory Frequency
Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Full Information
NCT ID
NCT02483221
First Posted
June 24, 2015
Last Updated
July 26, 2017
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02483221
Brief Title
Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCI-PCA
Arm Type
Active Comparator
Arm Title
PCA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Rating Score
Description
Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Time Frame
up to 17 hours after extubation
Secondary Outcome Measure Information:
Title
Modified Observer's Assessment of Alertness/Sedation Scale
Description
Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Time Frame
up to 17 hours after extubation
Title
Postoperative Nausea and Vomiting
Description
Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Time Frame
day of surgery
Title
Respiratory Frequency
Description
Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Time Frame
up to 17 hours after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jeleazcov, MD, MS
Organizational Affiliation
Department of Anesthesiology, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, University Hospital Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33547559
Citation
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.
Results Reference
derived
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Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA
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