The Effect of Perioperative Pregabalin on the Incidence of Chronic Post-thoracotomy Pain Syndrome

Chronic Pain Clinical Trial

Official title:

A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00998816
• Other study ID #: ANAE 153-09
• Status: Withdrawn
• Phase: Phase 3
• First received: October 20, 2009
• Last updated: April 10, 2012
• Start date: May 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2012
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (CPTPS).

Description:

A total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (Lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. While in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. Patients will be re-assessed at 2, 4 and 6 months following surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, ASA class I II or III

Exclusion Criteria:

• Inability ot adhere to study protocol:

• intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement

• inability to respond to the study questionnaire

• renal insufficiency(serum creatinine > 1.5 upper limit of normal)

• Body Mass index > 40

• planned post-operative ventilation.

• Confounding procedural factors which might affect validity of data:

• previous ipsilateral thoracotomy

• surgery for tumor extending into the chest wall

• rest pain in proposed surgical area pre-operatively

• chest tube in situ at time of surgery

• requirement for second thoracotomy or re-occurrence of disease after surgery *isolated pleuroscopy or pleurodesis procedures.

• Potential interaction with study medications and patient's current medications:

• current alcohol or other substance abuse

• chronic steroid use

• pre-existing chronic pain requiring chronic analgesic use

• history of seizure disorder requiring treatment with an anticonvulsant

• current therapy with thiazolidinedione class oral hypoglycemic agents (eg, Actos, Avandia or Avandamet)

• history of congestive heart failure

• major psychiatric disorder

• any contraindication to use of NSAIDs.

• Insufficient safety data in the patient population:

• patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding

• weight <50 Kg

• dizziness while inpatient.

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Pregabalin
pregabalin capsules (150mg,oral) will be administered 1 hour before lateral thoracotomy, 12 hours after the thoracotomy and then 12 h BID for 10 additional days.

Locations

Country	Name	City	State
Canada	Dr. Jorge E Zamora	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic post thoracotomy pain syndrome		6 months following surgery	No
Secondary	During hospital stay: pain intensity, PEF and FEV1, patient satisfaction, medication side effects. At 2, 4, and 6 months: pain intensity, pain quality (neuropathic versus other), quality of life, pain interference with daily function		During hospital stay and at 2, 4, and 6 months postoperatively	Yes