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CompletedNCT01923948Updated Mar 31, 2016

Preoperative Pain Control in Liver Surgery Patients

An interventional study of Pregabalin and Placebo (for Pregabalin) in Pain, Postoperative and Hepatocellular Carcinoma, sponsored by Eastern Hepatobiliary Surgery Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Pain, Postoperative
  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
  • Hepatectomy
  • randomized controlled trials(RCTs)
  • Postoperative Pain
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing partial hepatectomy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Pregabalin

    Single, 150 mg pre-operative oral dose of Pregabalin

    Drug: Pregabalin

  • Placebo comparator
    Sugar Pill

    Single, placebo pre-operative dose

    Drug: Placebo (for Pregabalin)

Interventions

  • DrugPregabalin

    One 150 mg oral dose of Pregabalin given before surgery

    Also known as: Lyrica

  • DrugPlacebo (for Pregabalin)

    One oral dose of placebo given before surgery

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

06

What researchers measure

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

07

Study locations

1 site
  • Eastern Hepatobiliary Surgery Hospital
    Shanghai, 200438, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01923948
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Aug 16, 2013
Start date
May 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Mar 31, 2016

Study contacts

li ai jun, MD
study chair · Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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