NCT02483221

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

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

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

June 24, 2015

Last Update Submit

July 26, 2017

Conditions

Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Modified Observer's Assessment of Alertness/Sedation Scale

    up to 17 hours after extubation

  • Postoperative Nausea and Vomiting

    day of surgery

  • Respiratory Frequency

    up to 17 hours after extubation

Study Arms (2)

TCI-PCA

ACTIVE COMPARATOR
Drug: Hydromorphone

PCA

ACTIVE COMPARATOR
Drug: Morphine

Interventions

HydromorphoneDRUG

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.

TCI-PCA
MorphineDRUG

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.

PCA

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33547559DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

HydromorphoneMorphine

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, MS

    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

June 24, 2015

First Posted

June 26, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

DE(1)