Hepatocellular Carcinoma, Pain, Postoperative
Conditions
Keywords
Hepatocellular carcinoma, Hepatectomy, randomized controlled trials(RCTs), Postoperative Pain
Brief summary
Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.
Detailed description
Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows: * Post-operative analgesic requirements * Post-operative VAS scale (rated 0-10) * Complications * Post-operative antiemetic requirement * Length of stay
Interventions
DRUGPregabalin
One 150 mg oral dose of Pregabalin given before surgery
One oral dose of placebo given before surgery
Sponsors
Eastern Hepatobiliary Surgery Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing partial hepatectomy
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Opioid Consumption | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Pain Scores on the Visual Analog Scale | 24 hours |
Countries
China
Outcome results
None listed