Preoperative Pain Control in Liver Surgery Patients | NCT01923948

Studies
Preoperative Pain Control in Liver Surgery Patients

NCT01923948

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Pain, Postoperative
Hepatocellular Carcinoma

Interventions

Pregabalin
Placebo (for Pregabalin)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 9, 2013

First Submission Date that Met QC Criteria

Aug 14, 2013

First Posted Date

Aug 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery HospitalPrincipal Investigator

Lead Sponsor

Eastern Hepatobiliary Surgery HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregabalin	Active Comparator	Single, 150 mg pre-operative oral dose of Pregabalin	Drug: Pregabalin
Sugar Pill	Placebo Comparator	Single, placebo pre-operative dose	Drug: Placebo (for Pregabalin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	One 150 mg oral dose of Pregabalin given before surgery	Pregabalin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Opioid Consumption		48 hours

Secondary Outcomes

Measure	Description	Time Frame
Postoperative Pain Scores on the Visual Analog Scale		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
li ai jun, MD	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern Hepatobiliary Surgery Hospital		Shanghai		200438	China

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin
D000073893	Sugars
D013607	Tablets

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided