Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome.

NCT00967135 | Completed

• 1 other identifier: PC 2010-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess:

1. 1.The impact of taking perioperative pregabalin on the incidence of chronic neuropathic pain and postthoracotomy syndrome at 3 months in patients who have undergone a thoracotomy with a thoracic epidural as the basic analgesic modality.
2. 2.The impact of taking perioperative pregabalin on the relief of acute pain, and on the use of additional analgesics, such as opioids, for the relief of such pain in patients who have undergone thoracic surgery with a thoracic epidural as the basic analgesia.
3. 3.The impact of taking perioperative pregabalin on the quality of life and level of functioning of patients who underwent thoracic surgery 3 months earlier.
4. 4.The safety profile of pregabalin in this patient population.

Conditions

Neuropathic Pain

Keywords

Thoracotomy; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Development of neuropathic pain and intensity of pain assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale and Brief Pain Inventory questionnaire (BPI).

  At 3 months

Secondary Outcomes (1)

• Intensity of postoperative pain using a Visual Numeric Pain Scale (VNPS).

  Day 1 to Day 4

Study Arms (2)

Pregabalin

EXPERIMENTAL

Study subjects will be randomized to receive on the morning of surgery, at least 30 minutes before induction, a 150 mg oral dose of pregabalin. Patients will then receive a 150 mg oral dose of pregabalin on the evening of the surgery. Subsequently, patients will receive a 150 mg oral dose of pregabalin twice daily on the following four postoperative days.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Study subjects will be randomized to receive a matching placebo on the morning of surgery, at least 30 minutes before induction. Patients will then receive a placebo on the evening of the surgery. Subsequently, patients will receive a placebo twice daily on the following four postoperative days.

Drug: Placebo

Interventions

Pregabalin DRUG

150 mg oral dose of pregabalin twice daily for 5 consecutive days.

Also known as: Lyrica

Pregabalin

Placebo DRUG

Matching oral placebo twice daily for 5 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years.
• Patients who are to undergo an elective thoracotomy in the lateral decubitus position.
• Patients who are ASA I to III inclusive.

You may not qualify if:

• A contraindication to pregabalin.
• A contraindication to the epidural technique.
• The current use of drugs belonging to the class of opioids, NMDA receptor blockers, membrane stabilizing agents (lidocaine mesylates, flecainide) or topical coanalgesics (capsaicin cream, lidocaine patch).
• Previous use of pregabalin or gabapentin.
• Preexisting pain at the site where the surgical incision will be made.
• Presence of a coexisting chronic pain syndrome.
• A creatinine clearance of less than 60 mL/min.
• A previous ipsilateral thoracotomy.
• A recent history of alcohol and/or drug abuse.
• A known allergy to local anesthetics or hydromorphone.
• The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• François Girard, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

CA (1)