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

NCT03211728 | Completed

• 1 other identifier: 4-2017-0415
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction

Outcome Measures

Primary Outcomes (4)

• Postoperative pain scores

  Visual analog scale (VAS) score = 0-100 mm

  12 hours after surgery

• Postoperative pain scores

  Visual analog scale (VAS) score = 0-100 mm

  24 hours after surgery

• Postoperative pain scores

  Visual analog scale (VAS) score = 0-100 mm

  36 hours after surgery

• Postoperative pain scores

  Visual analog scale (VAS) score = 0-100 mm

  2 weeks after surgery

Secondary Outcomes (1)

• Opioid consumption

  the first 48 hours after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

Drug: pregabalin

placebo group

PLACEBO COMPARATOR

Drug: placebo

Interventions

pregabalin DRUG

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

experimental group

placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 7, 2017
• Study Start: July 19, 2017
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)