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

Anterior Cruciate Ligament (ACL) Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211728
• Other study ID #: 4-2017-0415
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: February 8, 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament (ACL) Reconstruction
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores	Visual analog scale (VAS) score = 0-100 mm	12 hours after surgery
Primary	Postoperative pain scores	Visual analog scale (VAS) score = 0-100 mm	24 hours after surgery
Primary	Postoperative pain scores	Visual analog scale (VAS) score = 0-100 mm	36 hours after surgery
Primary	Postoperative pain scores	Visual analog scale (VAS) score = 0-100 mm	2 weeks after surgery
Secondary	Opioid consumption		the first 48 hours after surgery