Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy (PregabaNeph)

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00957177

PregabaNeph

Details and patient eligibility

About

Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.

Hyperalgesia is measured by von-Frey-Filaments.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients undergoing elective nephrectomy

Exclusion criteria

• contraindication against pregabalin
• creatinine > 2.0 mg/dl
• GGT >165, AST >105, ALT >135
• peptic Ulcus
• haemorrhagic diathesis
• angina pectoris, myocardial infarction
• stroke
• bronchial asthma
• opioid abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Pregabalin group

Active Comparator group

Description:

Receiving 300mg pregabalin preoperative

Treatment:

Drug: Pregabalin