Pain Therapy After Elective Cardiac Surgery

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Sufentanil, Hydromorphone

• Registration Number: NCT01490268
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil Group 2	Sufentanil, Hydromorphone	Sufentanil High Titration
Sufentanil Group 1	Sufentanil, Hydromorphone	Sufentanil Low Titration

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of sufentanil and hydromorphone	48 hours	28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics
Numerical Rating Scale for Clinical Pain	8 hours	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

Secondary Outcome Measures

Name	Time	Method
Total amount of hydromorphone	8 hours	Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale	8 hours	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

Trial Locations

Locations (1)

Department of Anesthesiology, University Hospital; 🇩🇪 Erlangen, Germany