Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 424 for:    Pregabalin

Preoperative Pain Control in Liver Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01923948
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Hepatocellular Carcinoma Drug: Pregabalin Drug: Placebo (for Pregabalin) Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin
Single, 150 mg pre-operative oral dose of Pregabalin
Drug: Pregabalin
One 150 mg oral dose of Pregabalin given before surgery
Other Name: Lyrica

Placebo Comparator: Sugar Pill
Single, placebo pre-operative dose
Drug: Placebo (for Pregabalin)
One oral dose of placebo given before surgery
Other Name: Sugar pill manufactured to mimic Pregabalin 150 mg tablet




Primary Outcome Measures :
  1. Postoperative Opioid Consumption [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Postoperative Pain Scores on the Visual Analog Scale [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923948


Locations
Layout table for location information
China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Layout table for investigator information
Study Chair: li ai jun, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Layout table for additonal information
Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01923948     History of Changes
Other Study ID Numbers: EHBHKY2013-001-09
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Hepatocellular carcinoma
Hepatectomy
randomized controlled trials(RCTs)
Postoperative Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Pregabalin
Carcinoma
Carcinoma, Hepatocellular
Pain, Postoperative
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants