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OpenTrials
Completed

NCT Number: NCT03211728

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

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.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.

Placebo

Drug

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

Primary outcomes

  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 outcomes

  1. Opioid consumption

    Time frame: the first 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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