Preoperative Pain Control in Liver Surgery Patients

NCT ID: NCT01923948

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Pain, Postoperative Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pregabalin

Single, 150 mg pre-operative oral dose of Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

One 150 mg oral dose of Pregabalin given before surgery

Sugar Pill

Single, placebo pre-operative dose

Group Type PLACEBO_COMPARATOR

Placebo (for Pregabalin)

Intervention Type DRUG

One oral dose of placebo given before surgery

Interventions

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Pregabalin

One 150 mg oral dose of Pregabalin given before surgery

Intervention Type DRUG

Placebo (for Pregabalin)

One oral dose of placebo given before surgery

Intervention Type DRUG

Other Intervention Names

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Lyrica Sugar pill manufactured to mimic Pregabalin 150 mg tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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li ai jun, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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EHBHKY2013-001-09

Identifier Type: -

Identifier Source: org_study_id

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