Pain Therapy After Elective Cardiac Surgery

Pain Clinical Trial

— PKPDHM-001  

Official title:

Pharmacokinetic-pharmacodynamic Modeling of the Postoperative Pain Sensation During Patient-controlled Analgesia With Target-controlled Infusion of Hydromorphone, Taking Into Account the Interaction With Intraoperatively Administered Sufentanil for Elective Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490268
• Other study ID #: PKPDHM-001
• Secondary ID: 2011-003648-31
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2011
• Last updated: December 5, 2014
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• 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

The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent,

• Ability to understand the nature of patient-controlled analgesia and other study-specific procedures,

• Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit

Exclusion Criteria:

• Use of MAO inhibitors in the last 14 days,

• Chronic alcoholism or drug addiction in medical history,

• Severe obstructive or restrictive pulmonal disorders in medical history,

• Severe hepatic and renal disorders in medical history,

• Hypothyroidism, pancreatitis in medical history,

• ASA IV,

• Pregnant or nursing females

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Sufentanil, Hydromorphone
Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
• Sufentanil, Hydromorphone
Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital	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 (4)

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

Saari TI, Fechner J, Ihmsen H, Schüttler J, Jeleazcov C. Analysis of total and unbound hydromorphone in human plasma by ultrafiltration and LC-MS/MS: application to clinical trial in patients undergoing open heart surgery. J Pharm Biomed Anal. 2012 Dec;71:63-70. doi: 10.1016/j.jpba.2012.07.025. Epub 2012 Jul 31. — View Citation

Saari TI, Fechner J, Ihmsen H, Schüttler J, Jeleazcov C. Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC-MS/MS: application to clinical pharmacokinetic study. J Pharm Biomed Anal. 2012 Jul;66:306-13. doi: 10.1016/j.jpba.2012.03.050. Epub 2012 Apr 3. — View Citation

Saari TI, Ihmsen H, Mell J, Fröhlich K, Fechner J, Schüttler J, Jeleazcov C. Influence of intensive care treatment on the protein binding of sufentanil and hydromorphone during pain therapy in postoperative cardiac surgery patients. Br J Anaesth. 2014 Oct;113(4):677-87. doi: 10.1093/bja/aeu160. Epub 2014 Jul 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of sufentanil and hydromorphone	28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics	48 hours	No
Primary	Numerical Rating Scale for Clinical Pain	11 assessments of patient's pain sensation using Numerical Rating Scale for Clinical Pain during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the analgesic effect	8 hours	Yes
Secondary	Total amount of hydromorphone	Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement	8 hours	No
Secondary	Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale	11 assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the sedation level	8 hours	Yes