Postoperative Pain Therapy With Hydromorphone Using TCI-PCA | NCT02035709

NCT02035709

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2013-002875-16	EudraCT Number

Status Module

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TCI-PCA	Active Comparator	Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion	Drug: Hydromorphone
PCA	Active Comparator	Intravenous Patient-Controlled Analgesia	Drug: Hydromorphone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydromorphone	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Measure	Description	Time Frame
Amount of Hydromorphone Administered	Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding the amount of hydromorphone administered	Day 1 (Visit 3 on first day after surgery)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Christian Jeleazcov, MD, Associate Professor	Department of Anesthesiology, University Hospital Erlangen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, University Hospital Erlangen		Erlangen	Bavaria	91054	Germany
Department of Anesthesiology, University Hospital Erlangen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23958818	Background	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.
33009192	Derived	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.

Condition Browse Module

ID	Term
D010149	Pain, Postoperative

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Intervention Browse Module