NCT01726205

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

3.6 years

First QC Date

November 9, 2012

Last Update Submit

November 9, 2012

Conditions

Post-thoracotomy Pain

Outcome Measures

Primary Outcomes (1)

  • Pain control

    5 days postoperatively

Secondary Outcomes (1)

  • morphine consumption

    3 days postoperatively

Other Outcomes (1)

  • side effects, pain at 1 and 3 months, incidence of neuropathic pain

    3 months

Study Arms (3)

pregabalin

ACTIVE COMPARATOR

perioperative pregabalin starting the evening before surgery, and for five days postoperatively

Drug: Pregabalin and normal saline infusion, PRG

pregabalin and continuous wound infusion

ACTIVE COMPARATOR

Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter

Drug: Pregabalin and ropivacaine 02% infusion

placebo

PLACEBO COMPARATOR

Placebo drug and normal saline infusion

Drug: Placebo drug, normal saline infusion

Interventions

Pregabalin and normal saline infusion, PRGDRUG
pregabalin
Pregabalin and ropivacaine 02% infusionDRUG
pregabalin and continuous wound infusion
Placebo drug, normal saline infusionDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for a thoracotomy,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon Hospital

Athens, Greece

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Tatiana Sidiropoulou

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

  • Eyaggelos Giavasopoulos

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Anesthesiology, University of Athens

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

October 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

GR(1)