Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?

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: NCT03211728
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament (ACL) Reconstruction Drug: pregabalin Drug: placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : February 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: experimental group Drug: pregabalin
The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.

Placebo Comparator: placebo group Drug: placebo
The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.




Primary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: 12 hours after surgery ]
    Visual analog scale (VAS) score = 0-100 mm

  2. Postoperative pain scores [ Time Frame: 24 hours after surgery ]
    Visual analog scale (VAS) score = 0-100 mm

  3. Postoperative pain scores [ Time Frame: 36 hours after surgery ]
    Visual analog scale (VAS) score = 0-100 mm

  4. Postoperative pain scores [ Time Frame: 2 weeks after surgery ]
    Visual analog scale (VAS) score = 0-100 mm


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: the first 48 hours after surgery ]


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:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 20-65 years
  • physical condition type I or II in ASA (American Society of Anesthesiology)

Exclusion Criteria:

  • patients of ASA classification 3 or more
  • with a history of cardiovascular or respiratory disease
  • dizziness or frequent headache
  • active alcohol or drug usage,
  • intake of any analgesics daily or 48 hours before surgery
  • impaired renal and/or hepatic function

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): NCT03211728


Locations
Layout table for location information
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03211728    
Other Study ID Numbers: 4-2017-0415
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
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
Psychotropic Drugs