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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Hydromorphone
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Therapy

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anesthesiology, University Hospital Erlangen
  • 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

Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion

Intravenous Patient-Controlled Analgesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numerical Rating Score
Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency

Full Information

First Posted
December 4, 2013
Last Updated
July 2, 2015
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02035709
Brief Title
Postoperative Pain Therapy With Hydromorphone Using TCI-PCA
Acronym
TCI-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) After Elective Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (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 concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Therapy

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 Description
Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion
Arm Title
PCA
Arm Type
Active Comparator
Arm Description
Intravenous Patient-Controlled Analgesia
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hydromorphone Plasma Concentrations
Description
Predictive accuracy of the "Erlanger pharmacokinetic model" of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage
Time Frame
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 Measure Information:
Title
Numerical Rating Score
Description
Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency
Time Frame
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 Pre-specified Outcome Measures:
Title
Amount of Hydromorphone Administered
Description
Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding the amount of hydromorphone administered
Time Frame
Day 1 (Visit 3 on first day after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jeleazcov, MD, Associate Professor
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
Facility Name
Department of Anesthesiology, University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23958818
Citation
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.
Results Reference
background
PubMed Identifier
33009192
Citation
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.
Results Reference
derived
PubMed Identifier
26797808
Citation
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.
Results Reference
derived

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Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

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