NCT01923948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1.6 years

First QC Date

August 9, 2013

Last Update Submit

March 30, 2016

Conditions

Pain, PostoperativeHepatocellular Carcinoma

Keywords

Hepatocellular carcinomaHepatectomyrandomized controlled trials(RCTs)Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Opioid Consumption

    48 hours

Secondary Outcomes (1)

  • Postoperative Pain Scores on the Visual Analog Scale

    24 hours

Study Arms (2)

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

PregabalinDRUG

One 150 mg oral dose of Pregabalin given before surgery

Also known as: Lyrica
Pregabalin
Placebo (for Pregabalin)DRUG

One oral dose of placebo given before surgery

Also known as: Sugar pill manufactured to mimic Pregabalin 150 mg tablet
Sugar Pill

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing partial hepatectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

Location

MeSH Terms

Conditions

Pain, PostoperativeCarcinoma, Hepatocellular

Interventions

PregabalinSugarsTablets

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydratesDosage FormsPharmaceutical Preparations

Study Officials

  • li ai jun, MD

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 16, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)