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Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA

NCT ID: NCT02483221

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Acute Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TCI-PCA

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

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.

PCA

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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.

Interventions

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Hydromorphone

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

Morphine

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Jeleazcov, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Hospital Erlangen

Locations

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Department of Anesthesiology, University Hospital Erlangen

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 33547559 (View on PubMed)

Other Identifiers

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TCI-PCA-002

Identifier Type: -

Identifier Source: org_study_id