Pregabalin and Post-thoracotomy Pain

NCT00663962 | Completed Phase 4 Results DMC

• 1 other identifier: ANAE-139-08
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.

Conditions

Chronic Pain

Keywords

Thoracotomy; Post-surgical; Pregabalin

Outcome Measures

Primary Outcomes (2)

• The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.

  2, 4, and 6 months

• Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively

  Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score \> 4 on a 10 point NRS scale)

  2 months postoperatively

Study Arms (2)

Perioperative pregabalin

EXPERIMENTAL

Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).

Drug: Pregabalin

Placebo control

PLACEBO COMPARATOR

An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)

Drug: Placebo

Interventions

Pregabalin DRUG

PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.

Perioperative pregabalin

Placebo DRUG

An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)

Placebo control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective thoracotomy (ET) or video assisted thoracotomy (VAT);
• Understanding and provision of written informed consent;
• Age \> 18 and \< 75;
• ASA class I, II or III.

You may not qualify if:

• Inability to adhere to study protocol;
• Intolerance or known hypersensitivity to any agents to be used in the study;
• Contraindication to thoracic epidural placement in open thoracotomy patients;
• Inability to respond to the study questionnaire;
• Renal insufficiency (serum creatinine \> 1.5 x upper limit of normal);
• BMI \> 40;
• Confounding procedural factors which might affect validity of data;
• Surgery for tumour extending into the chest wall;
• Requirement for second thoracotomy or re-occurrence of disease after surgery;
• Potential interaction with study medications and patient's current medications;
• Current ETOH or substance abuse;
• Pre-existing chronic pain requiring chronic analgesic use;
• History of seizure disorder requiring treatment with an anti-convulsant;
• Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos, Avandia, or Avandamet);
• History of congestive heart failure;

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pregabalin and Post-thoracotomy pain
• Organization: Queen's University

zamoraj@kgh.kari.net

(613) 548-7827

Study Officials

• Jorge E Zamora, MD

  Department of Anesthesiology Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 29, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)