Preoperative Pain Control in Liver Surgery Patients

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Pain, Postoperative; Hepatocellular Carcinoma

Treatments: Drug: Pregabalin; Drug: Placebo (for Pregabalin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01923948

EHBHKY2013-001-09

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

Single, 150 mg pre-operative oral dose of Pregabalin

Treatment:

Drug: Pregabalin

Sugar Pill

Placebo Comparator group

Description:

Single, placebo pre-operative dose

Treatment:

Drug: Placebo (for Pregabalin)