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OpenTrials
Completed

NCT Number: NCT01923948

Preoperative Pain Control in Liver Surgery Patients

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.

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Key information

Conditions

Pain, Postoperative Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

One 150 mg oral dose of Pregabalin given before surgery

Other names: Lyrica

Placebo (for Pregabalin)

Drug

One oral dose of placebo given before surgery

Other names: Sugar pill manufactured to mimic Pregabalin 150 mg tablet

Primary outcomes

  1. Postoperative Opioid Consumption

    Time frame: 48 hours

Secondary outcomes

  1. Postoperative Pain Scores on the Visual Analog Scale

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 16, 2013
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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