NCT02035709

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Dec 2013

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

December 4, 2013

Last Update Submit

July 2, 2015

Conditions

Postoperative Pain

Keywords

Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Numerical Rating Score

    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 Outcomes (1)

  • Amount of Hydromorphone Administered

    Day 1 (Visit 3 on first day after surgery)

Study Arms (2)

TCI-PCA

ACTIVE COMPARATOR

Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion

Drug: Hydromorphone

PCA

ACTIVE COMPARATOR

Intravenous Patient-Controlled Analgesia

Drug: Hydromorphone

Interventions

HydromorphoneDRUG

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.

PCATCI-PCA

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age between 40 and 85 years, both genders
  • Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Department of Anesthesiology, University Hospital Erlangen

Erlangen, 91054, Germany

Location

Related Publications (3)

  • 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.

    PMID: 23958818BACKGROUND

  • 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.

    PMID: 33009192DERIVED

  • 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.

    PMID: 26797808DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Christian Jeleazcov, MD, Associate Professor

    Department of Anesthesiology, University Hospital Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

January 14, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations

DE(2)