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

Acute Postoperative Pain Clinical Trial

Official title:

Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483221
• Other study ID #: TCI-PCA-002
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2015
• Last updated: July 26, 2017
• Start date: April 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2017
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• 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.
• 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.

Locations

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

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Score	Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	up to 17 hours after extubation
Secondary	Modified Observer's Assessment of Alertness/Sedation Scale	Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	up to 17 hours after extubation
Secondary	Postoperative Nausea and Vomiting	Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	day of surgery
Secondary	Respiratory Frequency	Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage	up to 17 hours after extubation