Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

Postoperative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035709
• Other study ID #: TCI-PCA-001
• Secondary ID: 2013-002875-16
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2013
• Last updated: July 2, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Hydromorphone
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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital Erlangen	Erlangen	Bavaria
Germany	Department of Anesthesiology, University Hospital Erlangen	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jeleazcov C, Saari TI, Ihmsen H, Mell J, Fröhlich K, Krajinovic L, Fechner J, Schüttler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Yes
Primary	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	No
Secondary	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	Yes