Preoperative Pain Control in Liver Surgery Patients

Hepatocellular Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923948
• Other study ID #: EHBHKY2013-001-09
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: March 30, 2016
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Pain, Postoperative

Intervention

Drug:
• Pregabalin
One 150 mg oral dose of Pregabalin given before surgery
• Placebo (for Pregabalin)
One oral dose of placebo given before surgery

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Opioid Consumption		48 hours	No
Secondary	Postoperative Pain Scores on the Visual Analog Scale		24 hours	No