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Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
This study is not yet open for participant recruitment.
Verified July 2017 by Yonsei University
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT03211728
First received: July 6, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
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Purpose
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 | Intervention |
|---|---|
| Anterior Cruciate Ligament (ACL) Reconstruction | Drug: pregabalin Drug: placebo |
| Study Type: | Interventional |
| Study Design: | 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: Participant, Care Provider, Investigator, Outcomes AssessorPrimary Purpose: Prevention |
| Official Title: | Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia? |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- Postoperative pain scores [ Time Frame: 12 hours after surgery ]Visual analog scale (VAS) score = 0-100 mm
- Postoperative pain scores [ Time Frame: 24 hours after surgery ]Visual analog scale (VAS) score = 0-100 mm
- Postoperative pain scores [ Time Frame: 36 hours after surgery ]Visual analog scale (VAS) score = 0-100 mm
- Postoperative pain scores [ Time Frame: 2 weeks after surgery ]Visual analog scale (VAS) score = 0-100 mm
Secondary Outcome Measures:
- Opioid consumption [ Time Frame: the first 48 hours after surgery ]
| Estimated Enrollment: | 96 |
| Anticipated Study Start Date: | September 1, 2017 |
| Estimated Study Completion Date: | August 31, 2018 |
| Estimated Primary Completion Date: | June 30, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years (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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211728
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211728
Contacts
| Contact: Yong Seon Choi, M.D., Ph.D. | 82-2-2228-2412 | yschoi@yuhs.ac |
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | Not yet recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Contact: Yong Seon Choi, MD, Ph.D +82-2-2228-2412 yschoi@yush.ac | |
Sponsors and Collaborators
Yonsei University
More Information
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT03211728 History of Changes |
| Other Study ID Numbers: |
4-2017-0415 |
| Study First Received: | July 6, 2017 |
| Last Updated: | July 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes 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 Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on July 11, 2017