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Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

U

University of Erlangen-Nürnberg Medical School

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Hydromorphone

Study type

Interventional

Funder types

Other

Identifiers

NCT02035709
2013-002875-16 (EudraCT Number)
TCI-PCA-001

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

40 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

TCI-PCA
Active Comparator group
Description:
Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion
Treatment:
Drug: Hydromorphone
PCA
Active Comparator group
Description:
Intravenous Patient-Controlled Analgesia
Treatment:
Drug: Hydromorphone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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