Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

Post-thoracotomy Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726205
• Other study ID #: PRGCWI1
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2012
• Last updated: November 9, 2012
• Start date: October 2008
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for a thoracotomy,

Exclusion Criteria:

• age >70 years

• BMI > 30

• preoperative Hb < 10 mg/dL

• preexistent chronic pain

• neurologic disease

• chronic assumption of alcohol

• treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-thoracotomy Pain

Intervention

Drug:
• Pregabalin and normal saline infusion, PRG

• Pregabalin and ropivacaine 02% infusion

• Placebo drug, normal saline infusion

Locations

Country	Name	City	State
Greece	Attikon Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	side effects, pain at 1 and 3 months, incidence of neuropathic pain		3 months	No
Primary	Pain control		5 days postoperatively	No
Secondary	morphine consumption		3 days postoperatively	No