Preoperative Pain Control in Liver Surgery Patients
Primary Purpose
Pain, Postoperative, Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pregabalin
Placebo (for Pregabalin)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Hepatocellular carcinoma, Hepatectomy, randomized controlled trials(RCTs), Postoperative Pain
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
Sites / Locations
- Eastern Hepatobiliary Surgery Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pregabalin
Sugar Pill
Arm Description
Single, 150 mg pre-operative oral dose of Pregabalin
Single, placebo pre-operative dose
Outcomes
Primary Outcome Measures
Postoperative Opioid Consumption
Secondary Outcome Measures
Postoperative Pain Scores on the Visual Analog Scale
Full Information
NCT ID
NCT01923948
First Posted
August 9, 2013
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01923948
Brief Title
Preoperative Pain Control in Liver Surgery Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Hepatectomy, randomized controlled trials(RCTs), Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
Single, 150 mg pre-operative oral dose of Pregabalin
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Single, placebo pre-operative dose
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
One 150 mg oral dose of Pregabalin given before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo (for Pregabalin)
Other Intervention Name(s)
Sugar pill manufactured to mimic Pregabalin 150 mg tablet
Intervention Description
One oral dose of placebo given before surgery
Primary Outcome Measure Information:
Title
Postoperative Opioid Consumption
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Postoperative Pain Scores on the Visual Analog Scale
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li ai jun, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Preoperative Pain Control in Liver Surgery Patients
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