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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03211728

Enrollment

Registered

2017-07-07

Start date

2017-07-19

Completion date

2019-02-08

Last updated

2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

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.

Interventions

DRUGpregabalin

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain scores	12 hours after surgery	Visual analog scale (VAS) score = 0-100 mm

Secondary

Measure	Time frame
Opioid consumption	the first 48 hours after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026